Content relating to Medical Devices

During this webinar, we’ll review an MDSAP audit from the perspe.ctive of an MDSAP Auditor

In this webinar, we’ll also review practical examples for the validation of software used in quality management systems and Quality Agreements with suppliers.

Medistar achieve ISO 9001 certification after completing their stage 2 audit remotely to accommodate the recent national travel bans

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).

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.

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 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.

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.

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.