Content relating to Medical Devices

Implementing the Medical Device Single Audit Program (MDSAP)
Watch our on-demand webinar to learn how to implement the Medical Device Single Audit Program (MDSAP).
Avoiding the Common Pitfalls to Successfully Implementing ISO 13485
This blog will help you avoid the common pitfalls to successfully implementing ISO 13485:2016.
Avoiding the Common Pitfalls to Successfully Implementing ISO 13485
Watch this on-demand webinar to learn about the common pitfalls to avoid in order to successfully implement ISO 13485 in your organization.
3 Most Common Non-Conformances to MDSAP Audits
To keep up with product innovation and industry growth, the medical device industry has seen some significant changes in regulation. Part of this, was the transition from ISO 13485, the international standard for Medical Device Quality Management Systems, to the Medical Device Single Audit Program (MDSAP).
Understanding the MDSAP Non-Conformance Scoring and Audit Report
One key change is the method used to identify and record non-conformances. The MDSAP does not recognize “Major” or “Minor” non-conformances but uses a grading system, that scores non-conformances on a point system ranging from 1 – 5, in a two-step process.
Navigating The MDSAP During COVID-19
Medical Device manufacturers around the globe are uniquely affected in this time of the COVID-19 Pandemic. Medical device products and services continue to be in high demand, and essential for hospitals and patient care providers. Medical device manufacturers are facing new challenges with being able to manufacture, procure and/or distribute critical medical products and components during this unprecedented period.
The 3 Challenges Commonly Experienced By Manufacturers Seeking Certification To The MDSAP
Due to changes in technical and regulatory requirements the Medical Device industry has recently experienced, many manufactures have struggled to keep up and comply with their requirements.
Why Implement the Medical Device Single Audit Program (MDSAP)?
MDSAP: The Readiness Checklist
Case Study
Medistar Achieve Certification After Completing Their Stage 2 Audit Remotely
Medistar achieve ISO 9001 certification after completing their stage 2 audit remotely to accommodate the recent national travel bans

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