#sscp

[centraldenoticiasmx]

Se fortalece coordinación entre instituciones para construir una sociedad más democrática y participativa

🖊#Ejecutivo | Se fortalece coordinación entre instituciones para construir una sociedad más democrática y participativa SABER MÁS:

La titular de la Secretaría de la Contraloría, Alejandra Pani Barragán, visitó las instalaciones de la Secretaría de Seguridad y Protección Ciudadana (SSPC), como parte de la agenda para fortalecer el cumplimiento de la declaración de situación patrimonial de las y los servidores públicos. Al respecto, la funcionaria estatal indicó que para la gobernadora Margarita González Saravia, la…

[iziel-healthcare]

What is Post-Market Clinical Follow-Up?

PMCF study is carried out for CE certified medical devices that are placed in the market. It’s a method of proactive collection of clinical data to analyze the emergent risks/side-effects of the medical device to demonstrate the safety and performance as per the intended purpose, throughout the expected lifetime of the device.

Performance and safety parameters are predefined with acceptance criteria based on the benchmark devices data, and milestones are designed for several PMCF studies and activities. The literature screening and registries study also supports PMCF findings. The sample size is predefined as per the sales of the device to study the emergent risks. Benefit-risk ratio analysis is performed as per the PMCF findings, for the acceptability of the device in the market. The PMCF findings are also documented in Technical Documentation, Risk File, SSCP, CER and PSUR

PMCF Includes

PMCF Procedure

PMCF Plan

PMCF Report

PMCF Plan

PMCF Protocol

Sample Size

Design of Milestones with follow-up period

Design of measurable endpoints for performance and safety

Ethical Committee approval

Questionnaire/Survey form

Patient/subjects consent form

Clinical Investigation/Trial procedure (if any)

Real World Evidence

Statistical Significance 

PMCF Report

Milestones completion

Real World Evidence analysis

Literature Screening

Registries

Questionnaires and Surveys results

Feedback from users/end user

Clinical Investigations/Trials results (if planned any)

Outcome of performance and safety endpoints

Risk benefit analysis

Residual Risks (if any)

Statistical Analysis

CER citation

Frequency of PMCF update

IZiel Healthcare offers PMS services to our clients where we perform end to end Post Market Surveillance activities. These services can be PMS Plan, PMS/PSUR Reports, PMCF Plan and Reports, Trend Reporting, Complaint Handling, Clinical Evaluation, Risk Benefit Management and many more.

We have expertise in designing PMCF Plan and drafting reports for our clients for all the Classes of Medical devices – Class IIa, Class IIb and Class III.

You may contact us at Contact Us – Iziel.

[acapulcopress]

Sheinbaum y AMLO recibieron un país hecho pedazos | Ricardo Monreal

CIUDAD DE MÉXICO * 12 de noviembre, 2024 ) Apro Luego de que el senador morenista Higino Martínez Miranda afirmara que debido a la violencia el país está viviendo un horror, durante su participación en Comisiones del Senado donde avalaron la reforma para fortalecer a la Secretaría de Seguridad y Protección Ciudadana (SSCP), el diputado Ricardo Monreal dijo que el senador no tiene razón, ya que el expresidente Andrés Manuel López Obrador y la actual presidenta Claudia Sheinbaum recibieron un país hecho pedazos. En entrevista en la Cámara de Diputados, el legislador enfatizó que el país va a recuperar la paz y tranquilidad y confía en la estrategia de seguridad del titular de la Secretaría de Seguridad y Protección Ciudadana (SSPC), Omar García Harfuch. “No, no tiene razón Higinio. La verdad es que el gobierno de la presidenta Claudia Sheinbaum y el gobierno del presidente López Obrador hace seis años recibieron un país hecho pedazos. Lo he dicho siempre, incluso escribí sobre eso hace 13, 14 años, un libro que se llama ´Escuadrones de la Muerte´ y describía la situación del país y la lucha ha sido incesante, constante, sin tregua, por eso no coincido con el senador Higinio. “El país va a recuperar su paz y tranquilidad, y ahora que vimos ayer a García Harfuch me da confianza la estrategia que se está diseñando, me da confianza en que vamos a recuperar nuestra tranquilidad y nuestra paz. No puedo secundar las afirmaciones del senador Higinio. Sí hay dificultades, nadie las puede negar, pero vamos a vencerlas y vamos a derrotar la violencia que hay en el país”, detalló. El día de ayer, durante su participación en las Comisiones que avalaron la reforma que fortalece a la SSCP, el senador dijo que debido a las matanzas que ha habido en el país, México está viviendo un horror. “Hay muchos reclamos en materia de seguridad en el pasado, de uno y de otros lados. Cuando lo que hoy tenemos que evitar es lo que sucede, lo que anoche sucedió en Cuautitlán, Izcalli, Estado de México, una masacre. A eso se le llama una masacre, una matanza de más de cinco personas y más heridos. O la de anoche, si no me equivoco, en Querétaro. Eso es lo que hoy no debe haber ya, o lo que pasó en Guerrero. “¿Quién habla ya de un presidente municipal, de una capital, de una entidad? De una capital, de una entidad que fue asesinada y decapitada. No sé si ya los detuvieron. O de la matanza de los comerciantes en Guerrero. De eso es lo que hay que hablar. Es lo que hay que aclarar, hay que parar. El horror que se está viviendo en este país. Sea el culpable quien sea. Para la ciudadanía, no hay culpables, para la ciudadanía lo que quieren es seguridad”, dijo. ) www.acapulcopress.com Read the full article

[christian-dubuis-santini]

Psy-op Covid: la commission ad-hoc de la Chambre des représentants des USA a publié son rapport final après une enquête de 2 ans…

https://oversight.house.gov/wp-content/uploads/2024/12/12.04.2024-SSCP-FINAL-REPORT.pdf

Rien ne filtre des médias français.

«Qui ne connaît la vérité n'est qu'un imbécile. Mais qui, la connaissant, la nomme mensonge, celui-là est un criminel.» (Berthold Brecht)

[mcyt-rpfinder]

﹒⌒ . SSCP ﹒⌗


> Protecting the country has always been a top priority for the government. Even when that involves some less kind practices... even when that involves secrete facilities run by suspicious business men.

Welcome one and all to Schlatt: Secure. Contain. Protect. A facility designed to keep supernatural and otherworldly entities contained and anyway from human life.

The server is 15+ and will contain a lot of gore though so if you don't like gore, violence, etc I would suggest not joining! We are also semi-lit to literate (meaning 2 paragraph minimum)

We allow QSMP Characters and DSMP Characters and have a lot open considering the server just opened!!

You can dm me on discord @ghOst.app if you're interested in joining!!

08/08/2024 ; 23:58 .

[unhonestlymirror]

My fellow medics, this is must-read for you:

"The House Select Subcommittee on the Coronavirus Pandemic has completed its two-year investigation and released its final report.

The team prepared more than 100 investigative letters, conducted more than 30 transcripts of interviews and depositions, and held 25 hearings and meetings, reviewing more than a million pages of documents.

Key Points:

1. The virus has biological characteristics that are not found in nature. The first people to become ill were the lab workers themselves.

2. The publication “The Proximal Origin of SARS-CoV-2,” which has been repeatedly used by officials to discredit the lab leak theory, was called out by Dr. Fauci to promote the preferred theory that COVID-19 originated in nature.

3. EcoHealth, led by Dr. Peter Daszak, used U.S. taxpayer dollars to support dangerous research in China.

4. The NIH’s procedures for funding and overseeing potentially dangerous research are flawed, unreliable, and pose a serious threat to both public health and national security.

5. The Paycheck Protection Program, which offered Americans significant relief in the form of forgivable loans, was rife with fraud, resulting in at least $64 billion in lost taxpayer money.

6. Fraudsters cost American taxpayers more than $191 billion; at least half of the money lost in relief programs was stolen by international fraudsters.

7. The COVID-19 vaccine did not stop the spread or transmission of the virus as promised.

8. The FDA rushed to approve a COVID-19 vaccine. Two top FDA scientists have warned their colleagues about the dangers of rushing the vaccine approval process and the potential for side effects. They were ignored, and mandatory vaccinations were introduced within days. (Remember, these same scientists resigned from the FDA COVID-19 vaccine task force.)

9. Vaccine requirements were not supported by science and did more harm than good.

10. Public health officials made a concerted effort to ignore natural immunity from COVID-19 when developing vaccination recommendations and requirements, and they often spread misinformation through conflicting messages and lack of transparency.

11. Vaccine injury reporting systems have created confusion, failed to adequately inform the American public, and undermined public trust in vaccine safety during the covid-19 pandemic.

12. As a result of school closures, students have faced historic learning loss, higher rates of psychological distress, and worse physical well-being. Standardized test results show that children have lost decades of academic progress, and mental and physical health problems have also increased dramatically, with suicide attempts among girls aged 12-17 up 51%.

Full report here (520 pages): - https://oversight.house.gov/wp-content/uploads/2024/12/12.04.2024-SSCP-FINAL-REPORT.pdf

It's worth remembering how some of our so-called “Doctors” (Ukrainian) called in intensive care units (!) not to provide medical care to the unvaccinated... I’d better keep silent about the rest of the bacchanalia, the fruits of which we are still reaping, so as not to open the wounds.

"There have been previous reports of the long-term presence of s-protein in the body after immunization and large amounts of foreign DNA in the drug, since the end of 2022 this is a new study.

"We analyzed the contents of RNA and DNA in the vials and detected large amounts of DNA after RNAse treatment in all batches with concentrations ranging from 32.7 ng to 43.4 ng per clinical dose. This far exceeds the maximum permissible concentration of 10 ng per clinical dose established by international regulatory authorities.

Genetic analysis with selected pairs of PCR primers proved that the residual DNA is not only fragments of DNA templates encoding the s-protein, but also all genes from the plasmid, including the sv40 promoter/enhancer (unfortunately, highly oncogenic) and the antibiotic resistance gene."

https://publichealthpolicyjournal.com/biontech-rna-based-covid-19-injections-contain-large-amounts-of-residual-dna-including-an-sv40-promoter-enhancer-sequence/

In Germany, the Institute for Molecular Diagnostics (Inmodia GmbH) offers tests to determine the presence of vaccine proteins or DNA plasmids in the human body:

"We focus on detecting spike proteins in tissue samples (including tumor material), measuring the concentration of spike proteins in blood or cerebrospinal fluid (including immune cells), and detecting "vaccine mRNA" and residual DNA (plasmid DNA).

We focus on finding out whether the sample contains spike proteins and whether they come from a COVID-19 injection or from a natural infection."

https://inmodia.de/en/

[darkmaga-returns]

Well, it’s out – a 577-page document that points out the failings of government during the scamdemic.

12.04.2024-SSCP-FINAL-REPORT.pdf

For those of us with eyes open, it contains a few false statements, but on the whole, it represents thousands of hours of work by politicians commenting on the acts of other politicians attempting to get to the bottom of a scam.

Here’s the 41-page press release that contains a summary of findings:

FINAL REPORT: COVID Select Concludes 2-Year Investigation, Issues 500+ Page Final Report on Lessons Learned and the Path Forward - United States House Committee on Oversight and Accountability

One obvious falsehood is this:

“OPERATION WARP SPEED: President-elect Trump’s Operation Warp Speed — which encouraged the rapid development and authorization of the COVID-19 vaccine — was highly successful and helped save millions of lives.”

Operation Warp Speed did not save millions of lives. The injections killed close to 750,000 Americans and did nothing – and were not designed – to prevent infection or transmission.

Trump desperately needs to listen to those voices with evidence of this and the lethal harms caused by Operation Warp Speed.

The report studiously avoids the evidence of extra and excess mortality as revealed in charts like this from here:

United States Deaths 2023, How Many Deaths in United States 2023 | Dead or Kicking

[centraldenoticiasmx]

Trasladan a 182 personas privadas de la libertad desde Morelos a otros Centros Federales

🖊️#Seguridad | Trasladan a 182 personas privadas de la libertad desde Morelos a otros Centros Federales +INFO:

Las primeras horas de este viernes, la Coordinación del Sistema Penitenciario del Estado de Morelos, en coordinación con el Órgano Administrativo Desconcentrado Prevención y Readaptación Social (OADPRS) de la Secretaría de Seguridad y Protección Ciudadana (SSPC), realizaron el traslado de 182 Personas Privadas de la Libertad (PPL), a diversos Centros Federales del país. Lo anterior, con la…

[nightguide]

dancing with the fantasy/the art of shutting up: Lorraine Kelly

you have a lot to say and you know your worth is to be kept preserved, which is why you don't have to feel insecure about speaking up, but i will help you relieve that part of you:

source: von Stumm, S., Chamorro-Premuzic, T. and Furn, A. (2008) Decomposing self-estimates of intelligence: Structure and sex differences across 12 nations. British Journal of Psychology, 100(2):429-42

Experimental psychologists:

how they shut you up - you sincerely know who's who, but you knew energetically there is a part of them (from experience) that has been holding you back from being the greatest version of you you've ever been, so you knew there was a limit in them that has to make you walk away from them to find your life elsewhere (usually they are younger than you)

goal - they would rather have it their way always (so they know there is a hierarchy to people pleasing that goes against their moral code intact to their soul believed in being than doing, so they're using you)

SARMAC members:

how they shut you up - they're the ones telling you to 'shut up' at every event you're at or at a gathering (they don't like you being better than them) they also know that you're pretty vulnerable 'to control', so they have a way in using you by making you believe that they are your friend which is how the empath/narcissist relationship exists early on, they know what it is like to be you, but they cannot help but become like you too heartfully that they exist without you even knowing in your sleep, so they took your dreams (hence why you're crying for your dreams to be around your friends right now truthfully) and made you live their worst because they cannot take an islamic hint

goal - they want to kill you personally (because their Dad is trying their best to make sure 'the right family' goes to heaven) which is completely misunderstood, like the Dad is a good guy, but the kid got too much 'attention' that they don't know what to do with it (you got autism an ur married an ur man has not come around for that reason 'BeCaUsE He CoNtRoLlEd YoUr RiGhTs iN eVeRy siNgLe wAy tHaT hE hAd A SpOlIeD ShItTy KiD ThAt hE HAd aN AfFaIr WiTh CuZ HE DID NOT SEE YOU'

SSCP members:

how they shut you up - they will do everything they can to remember a number and a month (death date) to see you as you are (their plan to take your life) which is how they can silence everybody after 'the day it happens' because they love the silence... before your true? life??? begins?... so they were now thinking.... and thats how the mom of that kid knows the hurt too too well because you knowing my blog was you being the ASD kid of a similar nature either you or you know a bff knowing you were trapped there that they lived it with you or knowing your intuition got hijacked (they hate your religion with a truthful heart)

goal - they will never understand you either way, their moral code is that they like what you want (nazar with a cause is destruction of all society: end times logic)

Clinical psychologists:

how they shut you up - they caused that death date, didn't they?. great, now you're TV famous as a historian, you got a great future ahead of you, now plan their forever by you being you by your Hollywood Islamic world inside of you out by preparing your haven (a blog) to be TV priority in you being you (your status is their fear) so be aware of your life about them to them and make it for them (you're the teacher now, so don't be confused.com)

goal - just be okay with finding true love to release you by bleeding (you intuitively know what that is but i'll publish an article about that sometime foreseeable to you in the future but be okay in the meantime that he is the one for you, never escape that thought in living but death is him, you were with that journey with me as your equal as i am to you as someone with PTSD, this is an agreeable journey for you to live on as one person living stronger than life)

Researchers:

how they do it - you're in pain, still. okay, have you met your Dad's eve (best friend like him like you) yet?

goal - you'll be healed in a day once knowing the time that lasts the same effect in comatose to their own character, like they're alive but not forgotten on TV

Practitioners:

how they do it - you're with him. at last

goal - the cure was you. there was a zombie apocalypse with a Selena Gomez that says 'the Qur'an is in my music'. it was her fan base that took control of your body for their 'unhealthy lives to go on at last'

Psychoanalysts:

how they do it - have sex with him (one night wonder)

goal - your life is now with your mother (the person you lost was you but she is you as you being you as her as you again <3)

Neuro-linguistic progressing therapists:

how they do it - you're very merciful to your own household, you find that under great care, is that you don't need to stress about your world with now, the Glee cast (new and occurring members with a device known to the Queen of Games: Viverra Network), you're known for your books available for the archives for Harper St. James for her honeymoon in Dubai with Rogue (Jonathan Groff), you're ultimately aware of the show's storyline and living along with it, knowing Harper is a primordial badass through her blog on Tumblr, just take your rage out on Anson Seabra

goal - Harper has a happy life for herself

Internal family system therapist:

how they do it - you love HSJ too much, now read Surah Al-Kahf (she's menstruating and ur prayers mean a lot to her)

goal - she wants the piemaker to erotically fall for her intervention as the Punisher in real time (crisis on infinite earths on DC/MARVEL intervention in real time)

Hypnotherapist:

how they do it - Harper will have a moment to herself with the piemaker like *he never had sex* they're virgins and he is not, so the word 'he' must be eliminated cuz future is female

goal - let her have sex

Undergraduates:

how they do it - know how your enemies work (cast of Glee and anybody who read my blog long enough to know the world of Glee as an American/British student abroad McKinley high as a new student at Hillcrest High) and write them down intuitively, you have that reason personally to get your life abroad and meet the cast of Glee in real life, they're not the assholes you think they are on the inside (trust me, i'm one of them)

goal - River Song gets married to Rogue on Doctor Who followed with a comeuppance of the 84th Doctor (Ncuti Gatwa) taking her on a racist journey ahead of time (with Ace)

General public in the United States:

how they do it - heartbreak is knowing your abilities in crafts (actors) have a reason to make a difference, so keep on doing it

goal - make Sue Sylvester work for your reputation to rise (as a working historian)

General public in the United Kingdom:

how they do it - you have a Jo (Harper's Sue Sylvester in the British Isles) you're more likely to think of Harper as an actor but that never changes when she met Jo for the first time (Uni lecturer now best friend), so you're more reliant on her philosophy than Sue Sylvester (which Jo calls 'her anime wayward life with American Harper St. James as she never had it (physically disabled)')

goal - the blog now has a dream, you made it happen so make that happen by you being you, so watch this interview specifically for you to see Lee Pace in real life (i sincerely thank you for your patience on my blog and your hopes with me, i look forward to meeting you in future now today that i know your dreams are as golden as mine, so you have the catalogue made for you and my upcoming online lectures in full reads, so don't be afraid and watch Lee's interviews starting with that one, so i'll give you tasks at the side for you to contain your dreams in metro-physical analogy of the Qur'an (i made you all Muslim, you're welcome)

you have the book to obtain it (don't ask me to give you mine or you're dead)

book: Psychology - G. Neal Martin (sixth edition) Pearson

p. 419

Fluid intelligence - how are you mentally defined in astrology as a beginner, how are you that dumb enough to preach your shitty analogy of the Qur'an online that you never heard of, so think of Sunni dawah. that man has a shitty way of talking about the dunya that you believe in an American solution (he did not lie to lead you but you were disturbed by his speech too acutely aware to be true about the 'right religion') so he made you quit to join a cult of youor own imagination now babies (ASD) are being raped by thoughts, now what will you do about him that makes you a justified astrologer now a practicing Muslim?

Crystallised intelligence - now you're dead to me.

Memory and learning - you're forgotten.

Visual perception - *piemaker is now the punisher and has a gun pointed to your head*

Auditory perception - you cry for your life or your heart breaks in disturbance to HSJ's life as a woman of a sincere passion as a succubus (prime wife)

Retrieval ability - you're married to HSJ but she does not like you, so you got hit by Gordon Ramsay as a 'God of all kitchens' now his war with Jamie Oliver took place as him being 'the Devil' made himself clear that he as a right to state his arts as a culinary master against Aziraphale (Oliver) to bleed for his rights to grab HSJ's pussy, so u working for him. gtfo of my auditorium

Cognitive speediness - so you're actually a good guy?

Processing speed - you're not even an astrologer you Paki

now watch my husband grape your thoughts. x

[blog-site-for-market-research]

Competitive Landscape Analysis of the Genotyping Market

Market Overview –

In 2022, the genotyping market was estimated to be worth USD 6.5 billion. The genotyping market is expected to expand from USD 7.94 billion in 2023 to USD 39.5 billion by 2032, with a compound annual growth rate (CAGR) of 22.2% over the forecast period (2023-2032).

The Genotyping Market involves the analysis of genetic variations in individuals to understand how genes contribute to health, disease, and other traits. Genotyping plays a crucial role in various fields, including biomedical research, personalized medicine, agriculture, and forensics. It enables researchers and healthcare professionals to identify genetic markers associated with diseases, drug responses, and other phenotypic traits.

In recent years, the genotyping market has experienced significant growth due to advancements in genomics technologies, decreasing genotyping costs, and increasing demand for personalized healthcare solutions. Key players in this market include biotechnology companies, pharmaceutical companies, academic research institutions, and diagnostic laboratories, collaborating to develop and commercialize genotyping assays and platforms.

Moreover, the adoption of genotyping in clinical settings has expanded with the rise of precision medicine approaches, which aim to tailor medical treatments to individual patients based on their genetic makeup. Genotyping allows healthcare providers to predict disease risk, optimize drug selection and dosage, and improve patient outcomes through targeted therapies.

The genotyping market is experiencing rapid growth, particularly in blood genotyping applications, driven by advancements in genetic research and personalized medicine. Blood genotyping enables precise identification of genetic variations, aiding in disease diagnosis, drug response prediction, and ancestry tracing. The market is fueled by increasing demand for personalized healthcare solutions and innovative genotyping technologies.

Additionally, the genotyping market is witnessing innovation in high-throughput genotyping platforms, next-generation sequencing technologies, and bioinformatics tools for data analysis. These advancements enable researchers and clinicians to perform large-scale genotyping studies, identify novel genetic variants, and gain deeper insights into complex genetic traits and diseases.

Overall, the genotyping market presents opportunities for growth and innovation as it continues to evolve with advancements in genomics and data analytics. Efforts to expand the applications of genotyping across different sectors and improve its accuracy, scalability, and cost-effectiveness are expected to drive further expansion in this market.

Market Segmentation –

The Global Genotyping Market has been segmented on the basis of technology, product, application, and end-user.

The technology segment has been segregated into sequencing, capillary electrophoresis, PCR, microarray, and mass spectrometry. The sequencing segment has been further divided into next-generation sequencing, pyrosequencing, and Sanger sequencing. The Capillary electrophoresis segment has been further divided into amplified fragment length polymorphism (AFLP),single-strand conformation polymorphism (SSCP), and restriction fragment length polymorphism (RFLP). The microarray segment has been classified as DNA microarrays, antibody microarrays, MMChips, and peptide microarrays.

On the basis of product, the market has been divided into reagents and kits, instruments, and services.

 The market, by application, has been classified into diagnostics, drug discovery and development, agriculture, academic research, and personalized medicine.

The end-user segment has been classified into hospitals, diagnostic centers, academic institutes, and research and development centers.

Regional Analysis –

Regional analysis of the genotyping market is pivotal for understanding the adoption, trends, and dynamics of this technology across different geographic regions. Genotyping, which involves the analysis of genetic variations, plays a crucial role in various fields such as research, clinical diagnostics, and personalized medicine. Factors such as healthcare infrastructure, research funding, and regulatory landscape vary significantly from region to region, influencing the market penetration and growth of genotyping technologies.

Developed regions like North America and Europe typically lead in genotyping adoption due to advanced research infrastructure, strong academic institutions, and robust healthcare systems. Conversely, emerging economies in Asia-Pacific and Latin America are witnessing increasing adoption of genotyping technologies, driven by factors such as growing investment in healthcare infrastructure, rising prevalence of genetic disorders, and increasing demand for personalized healthcare solutions.

Additionally, variations in regulatory policies and reimbursement schemes impact market dynamics and adoption rates across regions. Conducting a comprehensive regional analysis enables stakeholders to identify market opportunities, tailor their marketing strategies, and address region-specific challenges such as regulatory compliance and market access. By understanding regional nuances, companies can optimize their market penetration efforts and better serve the needs of researchers, clinicians, and patients worldwide.

Key Players –

Genotyping key companies include QIAGEN, Affymetrix, Illumina, Thermo Fisher Scientific, General Electric Company, Agilent Technologies, Fluidigm Corporation, Sequenom, Hoffmann-La Roche Ltd, Beckman Coulter, among others.

Related Reports –

Macrolide Antibiotics

Spinal Traction

Performance Enhancing Drugs

Vasectomy

For more information visit at MarketResearchFuture

[omcmedicalblog]

Switzerland Authorised Representatives | Swiss Medical Device Regulations | OMC Medical

Switzerland Medical Device Regulations

Medical devices are regulated: Swiss Agency for Therapeutic Product (Swissmedic) 

Current Switzerland Market Situation

As the Institutional Agreement is missing (InstA) is missing, the EU has not updated the Mutual Recognition Agreement(MRA)

No barrier free access to the EU internal market.

Swiss has been downgraded to the third country.

Swiss manufactures has stricter requirements when exporting their medical devices to the EU.

Manufacturer Responsibility

The center of the responsibility defined by law.

Prove and document conformity of his product, including correct classification.

Introduction and maintenance of a QMS system is his responsibility.

AR is dependent on the manufacturer to fulfil his obligations.

Manufacturer must be contractually obliged to guarantee the authorized representative full compliance of his legal duties.

Legal duties include- CE mark, UDI, IFU, Translation into Swiss languages.

Manufacturer must supply the AR with extensive documentation.

Manufacturer is obliged to retain the technical documentation, declaration, certificate of conformity, including amendments and supplements for 10-15 yrs.

AR to keep commercial records for 10 yrs.

Manufacturers outside Swiss

After 26 May 2021 , foreign manufacturers must appoint a Swiss authorised representative in order to sell their devices in the market.

Agreement between the manufacturer and the AR is needed.

Who is a Swiss AR

– Proxy to the foreign manufacturer – Responsible for product safety – Liable for product defects – Contact person for Swiss authorities – Can be legal entity or as a natural person – Must have access to PRRC

Swiss Authorised Representative

A Swiss authorised representative (Swiss AR) is a legal person appointed by a manufacturer established outside of Switzerland to place the products on the Swiss market.

A written mandate/letter designating an authorised representative for a medical device manufacturer is mandatory.

Manufacturers can appoint only a single Authorised representative in Switzerland.

According to the Swiss ordinance on medical devices, the authorized representative is responsible for any product defects. AR is jointly and severely liable for product defects with manufacturer.

Update for Manufacturers in EU & Swiss

Registration and notification obligations do not run via EUDAMED, but via Swissmedic.

Economic operators who have already placed products on the market before 26 May 2021 in accordance with the MDR and IVDR must complete their registration by 26 November 2021.

Access to the technical documentation may be provided either by keeping a copy available at the authorised representative or by contractually guaranteeing that it will be handed over to Swissmedic upon request within 7 days.

The validated Summary of Safety and Clinical Performance (SSCP) is not uploaded by the Notified Body in EUDAMED, but published by the manufacturer, for example on its website.

EU Manufacturer Exporting to Swiss

Need to appoint Swiss AR, update the labelling for MDR products & follow third country requirements.

Timeline to appoint Swiss AR:

Swiss Manufacturer Exporting to EU

For MDR regulated devices & class I devices: Follow third country requirements from 26th May 2021.

For MDD certified devices: No third country requirements, they will be regulated under MRA, free access to the EU market as before until May 2024.

How we assist you with this process?

Act as your Swiss Authorised Representative

MedDO compliance

EUDAMED registration

Product information translations in German, French, Italian language

EU MDR, IVDR gap analysis

Why Choose Us?

Working towards client satisfaction

Cost effective solutions

Project completion before deadline

Quality Regulatory affairs solutions

Originally Published at: https://omcmedical.com/switzerland-ar/

[evoldir]

Fwd: Graduate position: ImperialC_London.Three.InsectEvolution

Begin forwarded message: > From: evoldir@evol.biology.mcmaster.ca > Subject: Graduate position: ImperialC_London.Three.InsectEvolution > Date: 7 December 2023 at 06:06:10 GMT > To: rdmpage@gmail.com > > > > > Three PhD projects are being advertised to join the Gill group to conduct > research on aspects of insect ecology and evolution. > > An overarching aim for all three projects is to understand how insect > pollinator populations are being shaped by high rates of climate and land > use change, along with their plant partners and microbial symbionts. Gill > group webpage: https://ift.tt/n4CRPtJ > > Project 1: Climate impacts on Arctic plant-pollinator > networks: a population trait-based framework.  Deadline 8th > January (12:00 BST). A NERC SSCP funded project. For specific > project details, eligibility, and application information please see: > https://ift.tt/KNWR70H. > Note: Need to be classed as a UK home student. > > Project 2: Fungal disease risks under landscape homogenisation: tracking > fungal transmission across plant-pollinator networks using contemporary > and historic museum specimens. > > Deadline 15th January. A Leverhulme Centre > for the Holobiont funded project. For specific > project details, eligibility, and application information please see: > https://ift.tt/hOugk0v > Note: Need to be classed as a UK home student. > > Project 3: Leveraging entomological museum collections to understand > trait responses to environmental change over the past century. > Rolling deadline but encourage early interest. A chosen candidate for the > project would apply with the support of PI Gill to the following scheme: > https://ift.tt/QbrS95C. > If interested, please send an email to Richard Gill > (r.gill@imperial.ac.uk) explaining your interest in the topic and > an attached CV. If deemed suitable, PI Gill will contact you back to > discuss further. > > Note: Available to international students > > The positions are competitively funded, will be based at the Silwood > Park campus of Imperial College London, and if successful will start in > October 2024. > > Kind Regards, > > Dr Richard Gill > Dept. Life Sciences > > Silwood Park Campus > Imperial College London, UK > > "Gill, Richard J"

[humansofsscps]

“I went into freshman year with a boyfriend that was in junior year, our age was aging. I had like 3 people I was close with at the time, and that was like the start to my breaking point. I started smoking. I started drinking. I was skipping. I was beefing with my mother. I ran away. I had the cops called on me. That's literally why my mom sent me to SSCPS. She needed me to go somewhere far. I went to Brockton High, then Champion, then SSCPS. I would not go back to BHS, but I would go back to Champion; it definitely changed me for the better. I think people think my reputation is that I am mean, and I'm a gangster because of where I live. But I think I am a very kind hearted person, and that people walk over me so much more than what most people would think. In everybody’s head it's like, ‘Woah, hold on don’t mess with Deborah, she fights.'  No, I don't fight; y’all just push people to a certain extent. So it's like I think my reputation is what it shouldn’t be because I do think I can be a really kind person, and I love helping people, like, I’m understanding. The people I hang around with, it is very humbling. ‘Cause it's like, you know, the saying who you hang around with is who you are, yeah that's definitely true. ‘Cause like, wow, the people I used to hang around with, but I don't hang around them no more, and I have completely changed. Like my life a year ago and now are two completely different people, and I feel like people can see that.” -Debora Duviella

[bluenutavenue]

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