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

Navigating the Future: FDA’s Draft Guidance on AI-Enabled Medical Device Software

by Stefanie Wichansky on Feb 10, 2025 4:14:22 PM

Artificial Intelligence (AI) is revolutionizing healthcare, particularly in the medical device sector. AI-powered software is now integrated into...

Navigating Regulatory Shifts: How RFK Jr.’s Policies Could Impact Medical Device and Pharmaceutical Approvals

by Stefanie Wichansky on Jan 31, 2025 3:22:47 PM

Robert F. Kennedy Jr.'s potential influence on the U.S. healthcare regulatory environment could bring significant changes to the approval and...

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