Medical Device & IVD Usability Testing and FDA Human Factors Requirements

The technology behind your device may be brilliant, but sales will suffer if your user interface and/or ergonomics are subpar. Worse yet, you open your company and patients/users to risks that might have been avoided with proper device usability testing. FDA has long placed an emphasis on usability testing, which they refer to as human factors. In recent years, the European Union has also placed far more emphasis on risk management, an important facet of which is how the user […]

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FDA QSR vs. QMSR: What Medical Device Manufacturers That DO NOT Have ISO 13485 Certification Need to Know

For years, US FDA has been talking about aligning the existing FDA Quality System Regulation (QSR) with ISO 13485. FDA has finally taken concrete steps to do so by issuing a draft version of the new Quality Management System Regulation (now called “QMSR”). For US companies that export and have ISO 13485 certification, the update is welcome news. For the roughly 22%* of medical device companies that sell only in the US market, the impact on their QMS will go well beyond […]

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Evaluating and Accepting Medical Device and IVD Residual Risk

Medical device manufacturers and regulators generally have different goals, but one thing they have in common is a desire to make sure devices are safe and effective. To achieve that, regulatory managers often spend a substantial amount of time analyzing, evaluating, and controlling all manner of risks. Of course, risk can never be entirely eliminated, and despite your best efforts at controlling them, there will always be what is called “residual risk.” The question for many is how residual risk […]

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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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