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.

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Recent Posts

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 Medical Device Suppliers Must Act Now

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 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.

FDA Plans for 2018 – What Medical Device Companies Need to Know

by Stefanie Wichansky on Dec 29, 2017 1:58:55 PM

Good news for those Quality and Regulatory leaders eager to see what the FDA has in store for medical device companies in 2018! The FDA’s Center for...

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

by Stefanie Wichansky on Nov 21, 2017 12:45:17 PM

When the products that you manufacture are so integral to the health and well-being of your customers, it is of utmost importance that your products...

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...