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

Coronavirus Impact on EU MDR

by Stefanie Wichansky on Mar 28, 2020 2:07:33 PM

Medical device companies have been scrambling over the past few years to ensure compliance with EU MDR by the mandatory deadline of May 26, 2020....

Latest EU MDR News - Extension for Certain Class I Devices

by Stefanie Wichansky on Feb 11, 2020 1:38:01 PM

In December 2019, the European Parliament approved the second corrigendum of EU MDR. Typically, a corrigendum is comprised of minor corrections to...

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: 5 Critical Risks of Not Taking Action Now

by Stefanie Wichansky on Mar 19, 2019 8:49:37 AM

Five Critical Things You Must Know About the New ISO 13485

by Stefanie Wichansky on Feb 1, 2019 1:23:13 PM

 

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

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...

5 Reasons Why You Should Partner with PRP for 3rd Party Containment Services

by Stefanie Wichansky on Jan 22, 2019 11:32:21 AM

At PRP, we understand the challenges faced by automotive OEM's and suppliers, and we are committed to providing you with the top-notch 3rd Party...