The introduction of new and complex regulations, combined with the need to get safe and effective devices approved and into the market as quickly and...
What You Need to Know about SaMD, Artificial Intelligence, and Machine Learning
by
PRP Consulting Team on Aug 24, 2021 1:02:20 PM
5 Critical Points for Updating CERs
by
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...
EU MDR: Crucial 5-Step Action Plan to Start Now
by
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 new
6 Reasons Why You Should Partner with PRP
by
Stefanie Wichansky on May 22, 2018 1:48:22 PM
At PRP, we understand the challenges faced by Quality & Regulatory Compliance teams in the pharmaceutical and medical device industries. With an...
Major Regulatory Changes for Own-Brand Label (OBL) Manufacturers
by
Stefanie Wichansky on Apr 5, 2018 1:00:00 PM
Is your Company Ready for GDPR?
by
Stefanie Wichansky on Apr 3, 2018 12:16:00 PM
