ethandeower

[ethandeower]

Software as a Medical Device

Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical devices, tele-health, and digital health solutions. Most modern medical devices are manufactured with integrated software and software in general has become a deeply rooted part of medical industries the world over.

Medical software manufacturers and manufacturers of medical devices with integrated software must carefully consider the regulatory framework and new regulatory requirements to be able to put their software on the market.

While some regions have still not adopted regulations for medical device software, both the EU and the FDA have requirements for medical software and software as a medical device that rival those of traditional medical device regulations.

This content first posted by CiteMedial team Here https://www.citemedical.com/software-as-a-medical-device/

[ethandeower]

MEDDEV 2.7.1 Revision 4: Guidelines for Literature Search

The literature search and review is a fundamental part of your clinical evaluation report. A well-executed literature search should be carefully planned out and executed according to that plan.

But how do you demonstrate that the literature search was carried out as intended and did not miss any important information?

You document your literature search every step of the way!

This article from the Citemed team reviews the MEDDEV guidelines for literature search and provides an overview of the planning, execution, and documentation of your literature search.

Please don't forget to leave a comment if you found this article useful or if you think we left something out!  

This content is first posted at  https://www.citemedical.com/meddev-2-7-1-revision-4-guidelines-for-literature-search/

[ethandeower]

CAPA Management - Strategies Etc.

Did you know there is a gross misunderstanding of what entails the corrective and preventive measured of CAPA management? While these two often include similar actions, they are executed at different sites. For example, corrective measure is often linked with "containment". If a non-conformance is identified, the logical course of action is containment of the products that may have that issue. This is also part of the preventive measure. However, while the issue is being "corrected", the preventive measure also demands that the root cause of the issue is analyzed, which then requires analysis of the whole system or part of the system. The content first posted at https://www.citemedical.com/capa-process-with-eu-mdr/