Medical Innovation Exchange

PMS

Preparing for EU MDR Post Market Reporting

Preparing for EU MDR Post Market Reporting     EU MDR continues to pose challenges as companies prepare to recertify devices and bring new technologies to the European market. One of the big changes in the regulatory framework of EU MDR versus the current medical device directive (MDD) is the focus on post market surveillance (PMS) …

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Process and Planning Are Key to Successful EU MDR PMS Compliance

Process and Planning Are Key to Successful EU MDR PMS Compliance     In spite of continuing delays to implementation deadlines for Medical Devices Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), the requirements regarding Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), Post-Market Performance Follow-up (PMPF), and Person Responsible for …

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MedTech Regulatory Compliance: Join the Discussion and Expand Your Regulatory Networks

MedTech Regulatory Compliance: Join the Discussion and Expand Your Regulatory Networks     From cybsecurity to remote inspections, recalls and quality management, medical technology regulations are rapidly expanding. This increase in global regulatory demands has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory …

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