New Global Compliance Requirements Will Impact Medical Device Industry


Modern technologies can help prepare medical device and diagnostics companies for change.

The medical devices and diagnostics (MD&D) industry is on the verge of disruption, as new global compliance requirements are set to take effect. In March 2019, the 2016 revision to ISO 13485 will require the incorporation of risk management into every aspect of the quality management system. Also, the European Commission ratified new medical device regulations (MDR) for all European member states, while FDA released more than a dozen new medical device guidance documents in 2016 and 2017 that set new expectations for risk assessment.

As a result of these changing regulations, MD&D companies are urgently working to get ahead and update their operating processes. This means finding ways to increase operational visibility internally and externally, enable transparent content and data management across all functions, and improve efficiency—especially in clinical, where the number of studies is expected to increase dramatically.

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Article by Melonie Warfel 

November 8, 2017 in Regulatory and Compliance