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What Phases are Needed for Developing a Medical Device? Developing a medical device is an inherently complex process, and one that’s becoming more complicated all the time. In addition to the increasingly stringent regulatory requirements that must be met for FDA approval and/or EU MDR compliance, medical device manufacturers must also navigate ongoing changes […]
Building and then bringing a medical device to market as quickly as possible—all while preserving acceptable levels of quality and regulatory compliance—requires adept medical device risk management. By minimizing potential risks such as mislabeling and software-related issues, medical device manufacturers make each product safer for the patients who will use them. All of these risks […]
WEBINAR: TIR45 | An AGILE Approach to Software Regulatory Compliance Are you ready to seamlessly move from CLIA, Research Use Only (RUO) or Emergency Use Authorization (EUA) to a clinical software product? Join us as we discuss an AGILE approach to software regulatory compliance. We’ll be hosting this informative panel discussion with the owner of […]
We sat down with award-winning medical device risk management educator, author, and consultant Bijan Elahi to hear his thoughts on risk management in medical device development.
EU MDR which emphasizes patient safety, traceability, and transparency, will impact medical device developers, manufacturers, and suppliers across Europe.
3 improvement strategies to insert risk control as a crucial part of the medical device development framework to comply with ISO standards and EU MDR.
In the third installment of our 2020s Predictions series, we’re featuring medical device security predictions from Chris Gates, Principal Systems Security Architect at Velentium, a professional engineering firm specializing in the design and manufacturing of therapeutic and diagnostic active medical devices.
Despite ongoing concerns about cybersecurity, the medical device landscape has seen some amazing advances even just this year.
Today’s move-fast-get-it-to-market-yesterday product development culture puts a lot of pressure on companies to innovate quickly, but creating a safety-first culture can save you from product recalls and failure.
The US Food and Drug Administration (FDA) has issued new guidance that expands the Abbreviated 510(k) Program for medical device development and premarket notification submissions.