Complying with EU IVDR Postmarket Surveillance (PMS) Requirements

Once the IVDR takes effect, roughly 85% of all IVDs will be subject to Notified Body oversight. As such, manufacturers will be expected to compile detailed technical documentation prior to obtaining CE Marking certification or placing their device on the EU market. A critical piece of that documentation includes your plans and procedures for postmarket surveillance (PMS) – a fancy name for ensuring the ongoing safety and efficacy of your device. Despite the name and regardless of device risk, PMS […]

FDA Oversight of AI and Machine-Learning Medical Devices

The application of artificial intelligence (AI) and machine learning (ML) in medical device software is moving at breakneck speed. Money is flowing into AI / ML start-ups, and the technology holds huge promise for its ability to predict, diagnose, and manage patient health conditions. Still, in the race to be first to market, it is easy for some start-ups to overlook the current ground rules for medical device regulation established by FDA. For many, FDA’s detailed requirements for design control […]

How FDA Distinguishes Between Medical Device Servicing and Remanufacturing

Many medical devices eventually require preventative maintenance or repairs, and this vital service can be performed by a manufacturer, health institution, independent servicing organization (ISO), or third-party service company. In a 2018 report, FDA noted that their analysis of comments, complaints, and adverse events revealed that most serious issues were related to devices that had been “remanufactured” rather than instruments that had been “serviced.” The difference between the two may seem negligible, but it actually has profound compliance implications. Although […]

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All Topics, Design Control

ISO 14971 Certification Plus 5 More Medical Device Risk Management Myths

ISO 14971 has been the de facto international standard for medical device risk management for more than 20 years. If you want to sell your devices in the US or Europe, the standard will become an absolute necessity in your quest to obtain FDA clearance / approval for your device or CE Marking certification under the EU MDR or IVDR. ISO 14971 was initially known as EN1441 and was introduced in 1997. Soon after (in 1998), the first version of […]

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All Topics, ISO 14971/Risk Management

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