Medical Devices News & Resources

All articles related to Medical Devices Quality Assurance

  • Navigating the MDSAP during COVID-19

    Navigating the MDSAP during COVID-19

    To help combat the current pandemic, new measures have been introduced to assist medical device manufacturers plan for the future, remote audits. Remote audits use ICT to gather and evaluate evidence.

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  • Understanding the MDSAP Non-Conformance Scoring and Audit Report

    Understanding the MDSAP Non-Conformance Scoring and Audit Report

    The method used to identify and record non-conformances in the MDSAP has changed. It uses a grading system ranging from 1 – 5, in a two-step process.

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  • The 3 Challenges Commonly Experienced by Manufacturers Seeking Certification to the MDSAP

    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.

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  • 8 Factors to Prepare for your MDSAP Audit

    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...

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  • Maximizing your Certification to ISO 13485

    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.

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  • Preparing for a Successful Implementation of the Medical Device Single Audit Program

    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

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  • The ABC's of Medical Device Single Audit Program (MDSAP)

    The ABC's of Medical Device Single Audit Program (MDSAP)

    During this webinar we’ll discuss the key differences between MDSAP Audits and ISO 13485 QMS Audits.

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