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William A. Levinson
The martial arts rank, Shodan, for a first-degree black belt, does not mean “expert”; it means “first step.” ISO 9001:2015 is similarly a valuable and vital first step toward world-class performance...
    Globalization of the medical device market as well as its supporting supply chains continues to increase year after year. This has forced regulatory bodies to grapple with finding a way to narrow the gap between international and domestic regulation. In spring 2018 the United States Food and Drug...
    Innovation isn’t just about having a few bright ideas. It’s about creating value and helping organizations continuously adapt and evolve. ISO is developing a new series of International Standards on innovation management, the third of which has just been published. Innovation is an increasingly...
    The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible. The ASR program originally launched in 2000 when device manufacturers sought an “alternative summary” reporting exemption. ASR permitted...
    Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR). Class 1 medical devices must fully comply with the regulation by May 26, 2020, or be shut out of the region...

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