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Things to know about MDSAP in 2021.

The Medical Device Single Audit Program (MDSAP) was launched by the International Medical Device Regulators Forum (IMDRF) in 2014 on a pilot level. MDSAP allows similar recognized MDSAP Consulting Firms to conduct a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the relevant demands of the regulatory authorities that play a part in the program. The use of third-party auditors who have completed the  EU MDR Auditor Training allows the government resources to focus on high-risk medical devices and manufacturers that do not comply with the regulations.

What is the difference between MDSAP and ISO 13585:2016?

MDSAP is very much aligned with the ISO 13485:2016; however, there are some key differences:

Country-specific     regulatory requirements are included in an audit.

A     grading system based on QMS Impact and Occurrence aligns with Task Force     Quality Management System-Medical Devices.

The     assessment stages include document review and on-site assessment.

The     documentation process includes pre-market, post-market, recalls and     product notifications, design, development, and respective changes.

What is the MDSAP audit process?

The MDSAP process includes 7 key steps. These include:

Management

Device     Marketing Authorization & Faculty Registration

Measurement,     Analysis, and Improvement

Medical     Device Adverse Events

Design     and development

Production     and service controls

Purchasing

What are the benefits of MDSAP?

Like the FDA Quality Systems Regulations, MDSAP considers whether the regulatory processes are being followed during the manufacturing of a medical device.

During an MDSAP audit, the country-specific regulatory requirements are taken into consideration. Regulators will use the MDSAP audit report to substitute for the evidence of the manufacturer’s QMS certifications.

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Strategic planning of medical device.

The rapidly changing and complex regulatory environment in the global medical devices industry has resulted in the need for organizations to strengthen their safety and risk management practices in MDR transition training and improve their core set of expertise, all while reducing their operating model costs. Traditional operating models are being pushed to the point of breaking because of cost pressures, emerging competition, governmental and political demands and the weight of supporting global distribution channels. Not knowing what we don’t know, managing the complexity of the process, lack of specialists and resources and the ability to manage spikes are key issues medical device companies are facing from development to post-marketing monitoring.

From Medical Device Strategy Consulting and regulatory oversight to managing regulatory processes and preparing submissions, our global experience across all device types helps pave our path to market success. The investment in building cutting edge expertise and delivery models and services which complement our medical device client’s needs. We specialize in scientific knowledge-based processes and provide end-to-end services in a cost-effective manner. Our flexible approach also allows us to pick and choose activities within our service portfolio. By offering an integrated product delivery solution approach and leveraging our domain, process and technology expertise, we help our customers:

·         Ensure that they meet the ever-changing global regulatory landscape and achieve 100% compliance

·         Integrate clinical and commercial strategies to prove unique value

·         Balance resourcing as our portfolio adjusts to pipeline, regulatory and market fluctuations

·         Lower risk and maximize value in MDD to MDR transition training course during product commercialization

·         Reveal our product’s value to regulators, payers, providers and patients

·         Make “go/no go” decisions through the entire product lifecycle

For more details on this, please browse www.mdrconsultants.com.

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Concept of MDR and MDD.

The Medical Device Directive (MDD) will be replaced by the new Medical Device Regulation (MDR). MDR is designed to be an improved version of MDD, with the major difference being that MDR influences and provides effectiveness to all EU member states. This allows MDD to MDR transition training course to provide a regulation which is consistent and fair to all member states, increasing the standards on quality and safety measures.

Not only will the EU MDR Gap Assessment will widen to include all 27 EU member states (excluding the UK), but the guidelines included will also urge companies to undertake action and improve on their current product hygiene and safety, thus vastly improving their overall standards.

The MDR document is four times longer than the MDD, and puts more emphasis on product safety. Nothing from within the MDD has been removed; rather the MDR has added some new requirements. The regulations within the law require companies to review and improve their portfolios, thus implementing the required changes in order to remain compliant.

The MDD came into law in 1992, and is therefore outdated. For example, Software as a Medical Device (SaMD) did not yet exist. Furthermore, apps that patients used to monitor their own health did not yet exist.

The average age in Europe has also seen an increase since 1992, and this brings greater risks in medical device malfunction. To combat this, medical device single audit program of MDR has put stricter regulations on product life cycle, in order to increase overall product hygiene.

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How does Medical Device Consulting Firms ease our lives

Doctors and medical staff are considered to be synonyms of the god. Even in the harshest of days, they stand on their toes to provide their services to people. And their medical devices help them working even on the toughest medical cases. Medical devices are very important from the perspective of a medical practitioner. If the medical device is not made of good quality it might cost someone their life. Therefore, it is very important to use tested medical devices in the hospitals.

How to judge the quality of medical devices?

Every country has a medical community that looks after every aspect of the medical profession. There are Medical Device Consulting Firms which checks quality and help manufacturer to attain precision. In a few countries, it is also mandatory that the product should be ISO 13485 Medical Devices. It is not a standard to confirm the quality of a medical device but it is compulsory in some countries for the product to launch in the market. Quality management systems for medical devices are very strict and advanced.

What are Medical Device Consulting Firms?

Medical devices consultancy allow device manufacturer to produce best quality products. These are professionals who have hands-on experience with medical devices and their qualities. It allows them to check and test the product and certify them for market use. This allows quality and safe products to reach medical practitioners without any uncertainty. Consultants also help device manufacturers in the design updating process, approval process from medical authorities, and post-market requirements to stay up to date. 

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Concept of analyzing gap in an organization.

An EU MDR gap analysis process allows organizations to determine how to best achieve their business goals. It compares the current state with an ideal state or goals, which highlights shortcomings and opportunities for improvement.

Here are four steps of analyzing gap.

1. Analyze our current state

First, we will need to choose which area of our business we want to focus on and start with our current state. We need to discover where our organization currently is before we can make a plan for reaching our goals.

2. Identify the ideal future state

Once we have the big picture figured out and understand how our team or organization currently functions, we need to become idealistic.

3. Find the gap and evaluate solutions

Completing the first two steps of QMS Consulting in isolation won’t get us great results––the status quo can seem inescapable, and goals can feel lofty and unattainable. Putting them together, however, exposes what’s missing between our performance and our potential. We also need to decide which solutions will most effectively bridge the gap.

4. Create and implement a plan to bridge the gap

After we have charted out the possible ways to bridge the gap and decided which would be best, we likely still need to convince others in our organization of that as well. The changes that we will implement may also affect other teams and department, so it’s important to come up with a plan.

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