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 Common Pitfalls of EU MDR and How to Avoid them in 2025

by Stefanie Wichansky on Mar 17, 2025 6:00:15 PM

The European Medical Device Regulation (EU MDR) continues to pose challenges for medical device manufacturers as they strive for compliance. With...

Navigating the FDA's Latest Guidance on AI/ML in Medical Devices

by Stefanie Wichansky on Mar 17, 2025 3:40:22 PM

Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing the medical device industry by enabling adaptive, data-driven...

Which QMS Certification is Right for Your Company?

by Stefanie Wichansky on Mar 17, 2025 3:30:48 PM

For medical device companies, compliance with international quality standards is essential to ensure product safety, regulatory approval, and...

Avoiding FDA Inspection Findings: A Guide for Pharmaceutical and Biotech Companies

by Stefanie Wichansky on Feb 10, 2025 4:59:21 PM

How Medical Device Companies Can Avoid FDA Inspection Findings – And the Consequences of Noncompliance

by Stefanie Wichansky on Feb 10, 2025 4:53:04 PM

For medical device companies, compliance with FDA regulations is not just a legal obligation—it is critical to ensuring patient safety, product...

Donor Eligibility for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): FDA’s Evolving Guidance

by Stefanie Wichansky on Feb 10, 2025 4:47:01 PM

The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the safety of Human Cells, Tissues, and Cellular and Tissue-Based...

FDA’s Perspective on AI in Drug and Biological Product Development

by Stefanie Wichansky on Feb 10, 2025 4:19:14 PM

Artificial Intelligence (AI) is rapidly transforming the pharmaceutical and biotechnology industries, offering powerful tools to accelerate drug...