Medical device companies have been scrambling over the past few years to ensure compliance with EU MDR by the mandatory deadline of May 26, 2020....
Latest EU MDR News - Extension for Certain Class I Devices
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Stefanie Wichansky on Feb 11, 2020 1:38:01 PM
In December 2019, the European Parliament approved the second corrigendum of EU MDR. Typically, a corrigendum is comprised of minor corrections to...
5 Critical Points for Updating CERs
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Stefanie Wichansky on Mar 20, 2019 5:07:13 PM
The new European Union Medical Device Regulation ("EU MDR") represents one of the most significant and impactful regulations within the medical...
Five Critical Things You Must Know About the New ISO 13485
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Stefanie Wichansky on Feb 1, 2019 1:23:13 PM
One of the most prominent regulations within the medical device industry is ISO 13485, which specifies requirements for a quality management...
EU MDR: Crucial 5-Step Action Plan to Start Now
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Stefanie Wichansky on Jan 23, 2019 9:40:33 AM
Since the 1990’s, there had been very few updates to European regulations in the medical device industry. That all changed in May 2017, when the...
5 Reasons Why You Should Partner with PRP for 3rd Party Containment Services
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Stefanie Wichansky on Jan 22, 2019 11:32:21 AM
At PRP, we understand the challenges faced by automotive OEM's and suppliers, and we are committed to providing you with the top-notch 3rd Party...