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

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.
Recent Posts
Navigating the FDA's Latest Guidance on AI/ML in Medical Devices
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?
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
How Medical Device Companies Can Avoid FDA Inspection Findings – And the Consequences of Noncompliance
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
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
Artificial Intelligence (AI) is rapidly transforming the pharmaceutical and biotechnology industries, offering powerful tools to accelerate drug...