Stefanie Wichansky

Stefanie Wichansky

Stefanie Wichansky is the founder and CEO of PRP (www.prp-us.com), a certified woman-owned business that provides Quality and Regulatory Compliance consultants for medical device and pharmaceutical companies. Prior to launching PRP, she was a Manager at Deloitte before moving on to Partner at a mid-sized consulting firm. Stefanie received her MBA from Columbia Business School.

Find me on:
 

Recent Posts

EU MDR - 6 Significant Impacts on Clinical Evidence

by Stefanie Wichansky on Mar 27, 2018 1:02:00 PM

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...

IVDR – What Diagnostics 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.

How to Prevent an FDA Warning Letter by Understanding the Challenges of your Peers: September 2017

by Stefanie Wichansky on Oct 11, 2017 9:56:41 AM

As a quality manager in the medical device or pharmaceutical manufacturing industries, you surely understand the importance of planning ahead for...

Why Suppliers Should Focus on Supplier Diversity

by Stefanie Wichansky on Aug 17, 2017 2:18:20 PM

Are you a supplier to pharmaceutical and medical device companies? If so, you should be taking a hard look at your own supplier diversity...

Challenges your Peers are Having with the FDA and How to Avoid Them

by Stefanie Wichansky on Aug 14, 2017 2:10:45 PM

 Whether your company manufactures pharmaceuticals or medical devices, your goal as a Quality manager should be to create a culture of quality so...

How to Approach a Remediation

by Stefanie Wichansky on Jun 14, 2017 11:09:27 AM

It’s the piece of paper that you never want to see come across your desk. You’ve received a warning letter or an FDA 483 and you’re now being faced...