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December 9, 2019 – Global Regulatory Update

December 10, 2019 admin Leave a comment

Saudi Arabia Saudi Arabia’s Saudi Food and Drug Authority (SFDA) has rolled out a single registration platform for all medical…

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Post-Market Surveillance

December 2, 2019 admin Leave a comment

Medical device post-market surveillance (PMS) activities are described in the European Medical Device Directive (93/42/EEC) and are part of the…

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FDA Guidance​ Documents

October 27, 2019 admin Leave a comment

The US FDA has produced the A-List of Guidance Documents that CDRH intends to publish in FY2020.  A-List: Prioritized Guidance…

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U.S. FDA Medical Device Update

October 12, 2019 admin Leave a comment

Everyone, This is a very important regulatory update: U.S. FDA Medical Device Update US Food and Drug Administration medical device user…

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Recent Posts

  • December 9, 2019 – Global Regulatory Update
  • Post-Market Surveillance
  • FDA Guidance​ Documents
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