It's a question that, even after careful consideration, can seem difficult to answer: Does the FDA actually "require" medical device manufacturers to perform risk analysis? If so, where?

The short answer is yes. But the topic requires a more nuanced discussion. We've summarized where the confusion stems from and how and where regulators require risk analysis below.

 

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The release of the Medical Device Regulations (EU-MDR) has put significant pressure on medical device companies to closely scrutinize the new regulations, assess the impact on their own organization, and implement compliant processes and procedures accordingly.

As important deadlines approach for implementing the final version of the EU-MDR, medical device manufacturers should be focused on planning and implementing their transition program now.

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In 2015 and 2016, there were over 150 major medical device company acquisitions and mergers, and that trend has only accelerated in 2017. These events often bring important questions regarding quality that can have far-reaching consequences if not addressed thoroughly by both department and company leadership.

We've compiled insights from experts with firsthand experience helping device manufacturers make informed decisions when integrating quality systems and performing the due diligence necessary to ensure compliance in both the short and long term.

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On October 24, FDA finalized two guidances offering insight into when a new 510(k) is required following changes made to medical devices or the software powering them.

The drafts of these two guidances were released in the fall of 2016, five years after FDA's initial attempt at replacing its 1997 guidance outlining 510(k) changes. Deciding When to Submit a 510(k) for a Change to an Existing Device (“2016 Device Change Guidance”) revised FDA's 1997 guidance of the same name. The other, Deciding When to Submit a 510(k) for a Software Change to an Existing Device (“2016 Software Device Change Guidance”), presents guidelines for particular software changes.

Regulators have stated that the final versions of the guidances have been updated for clarity and to ensure they are interpreted consistently by agency staff and device manufacturers.

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As reported in a recent Regulatory Focus article for the Regulatory Affairs Professionals Society (RAPS), officials from two international regulators and representatives from auditing organizations offered the latest on the Medical Device Single Audit Program (MDSAP), confirming a fast-approaching deadline.

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