GLOBAL REGULATORY MONITOR
Emergo is a global medical device regulatory consulting firm whose quarterly series for Med Device Online will provide updates on new developments in international medical device regulations. Established in 1997 to help U.S. medical device companies export to Europe, Emergo has grown to serve more than 2,700 medical device and IVD clients worldwide. With offices in 25 countries, Emergo assists companies with global regulatory strategy, device registration, quality management system compliance, clinical trial consulting, in-country regulatory representation, and distributor qualification.
For more information, visit emergogroup.com
ARTICLES BY EMERGO
MDSAP: Ready for Prime Time?
With MDSAP’s multi-year pilot set for completion at the end of December, followed by full implementation early in 2017, manufacturers may question whether the program actually is ready. Ongoing gaps in coordination between some participating regulators, as well as low to middling participation rates so far among device manufacturers, may result in a less than auspicious launch.
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Preparing For New European Medical Device And IVD Regulations
Although final publication of the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) is unlikely to occur before early 2017, companies now can map out transition and compliance plans with more certainty. Here, we’ll discuss the crucial considerations that firms should weigh in the meantime.
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Preparing For The New EU Medical Device Regulations — A Eudamed Sneak Peek
When European lawmakers and regulators first indicated plans to overhaul legislation on how the union oversees medical devices and in vitro diagnostics (IVDs) in 2010 and 2011, industry participants knew such changes to the world’s second-largest device market would be anything but sudden.
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