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September 12, 2023
This year’s gathering of regulatory affairs professionals will take place in Montréal, QC Canada on October 3–5, 2023.
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Medical Device and IVD Solutions
Let NSF take you further with consulting, training and auditing services for medical device, IVD and combination product manufacturers.
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Resources
Germany Focuses on Digital Health Applications (DiGAs)
Read our article in the Journal of Medical Device Regulation on data protection and security and the positive care effects of digital health applications.
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Working With the FDA on Medical Device Recalls
Ashley Kelleher, Senior Medical Device and IVD Consultant at NSF, talks about working with the FDA on medical device recalls.
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Ten Steps to an Effective Medical Devices FDA 483 Response
Well documented FDA 483 observations can support FDA official actions. An effective and timely response to FDA 483 observations may help your organization avoid such actions.
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News and Events
February 2023 Medical Device and IVD News Update
February 15, 2023
This month we'll look at key FDA policies, procedures, and practices before, during and after inspections, provide tips for writing effective nonconformity statements during QMS audits, and more.
January 2023 Medical Device and IVD News Update
January 23, 2023
Welcome to our new Medical Device and IVD news update. Every month we'll bring you the latest medical device and IVD industry news, useful articles and resources, expert advice, training, and events for your calendar.
European Commission Puts the Delay to EU MDR Transition Timelines to the Vote
January 11, 2023
The European Commission published its proposal paper on the transition provisions for medical devices and in vitro diagnostic medical devices on January 6, 2023, it sets out the new transition deadlines and is a must read for the MedTech industry.