Important Changes to ISO 13485 2016 for Medical Device Manufacturers, Designers

In 2016 new ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes were published. This set into play a new international framework for requirements in an effort to mitigate risk in the production of compliant, reliable medical devices. Companies are granted a 3-year transition period. Are you ready? 

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Topics: quality assurance, regulatory control, ISO 13485

Strategies and Standards for Medical Device Signal Detection

In 2012, the Center for Devices and Radiological Health (CDRH), a branch of the U.S. Food and Drug Administration, announced four long term strategies to strengthen its National System for Medical Device Post-Market Surveillance1. Find out how these strategies correlate with medical device signal detection and why medical device firms can benefit from selecting a contracting partner with experience in Pharmacovigilance requirements.

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Topics: quality assurance, regulatory control