Content relating to Medical Devices

Preparing For A Successful Implementation Of The Medical Device Single Audit Program
During this webinar, we’ll review an MDSAP audit from the perspe.ctive of an MDSAP Auditor
Maximizing Your Certification To ISO 13485
In this webinar, we’ll also review practical examples for the validation of software used in quality management systems and Quality Agreements with suppliers.
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
The Top 3 Common Non-Conformities in the MDSAP
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 ABC’s Of Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) was created by the International Medical Device Regulators Forum (IMDRF) to enable audits that encompass ISO 13485 as well as the regulatory requirements from the United States, Canada, Australia, Brazil and Japan.
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.
8 Factors To Prepare For Your MDSAP Audit
The Medical Device Single Audit Program, or MDSAP, is a program that allows medical device manufacturers to be audited once for compliance with the ISO 13485 standard AND regulatory requirements of participating countries.

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