Five Critical Things You Must Know About the New ISO 13485

by Stefanie Wichansky on Feb 16, 2018 11:30:00 AM

One of the most prominent regulations within the medical device industry is ISO 13485, which specifies requirements for a quality management...

The New EU MDR – A Call to Action for Manufacturers

by Mark Neal on Feb 16, 2018 11:00:00 AM

At PRP,  we believe that staying connected to Pharmaceutical and Medical Device experts is paramount to gathering the key information necessary to...

The New EU MDR: 5 Action Steps Quality and Regulatory Professionals Must Take

by Stefanie Wichansky on Feb 16, 2018 10:45:00 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...

MDSAP Is Here, What Medical Device Manufacturers Need to Know

by Stefanie Wichansky on Feb 16, 2018 10:30:00 AM

The Medical Device Single Audit Program (MDSAP) allows for medical device manufacturers to undergo a single regulatory audit that covers the...

MedAccred – Why the Medical Device Industry is taking Notice

by Stefanie Wichansky on Feb 16, 2018 10:00:00 AM

The MedAccred program is making a big splash in the medical device industry. Learn what MedAccred accreditation is and how it may impact your...

IVDR – What Medical Device Companies Need To Know

by Stefanie Wichansky on Feb 16, 2018 9:30:00 AM

IVDR (In Vitro Diagnostic Regulation) impacts all in vitro devices sold in EU markets. Learn what this means for you.

Integrating Risk Management into a Process Approach for the New ISO 13485:2016

by Taryn Kern on Jan 2, 2018 12:15:01 PM

The definitions of ‘process approach’ and ‘risk management’ in ISO 13485:2003[i] have definitely left some gray areas for organizations over the...