Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
Expert guidance for industry professionals and clear, reliable information for patients and consumers
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
Where Regulatory and Quality Functions Intersect
At Medical Devices and Pharma, we understand that the seamless interaction between Regulatory Affairs and Quality functions...
FDA Enforcement
The Food and Drug Administration (FDA) in the United States employs various enforcement mechanisms to ensure compliance...
Overview of ISO 13485
ISO 13485, Medical devices quality management systems ISO 13485, Medical devices quality management systems, is an...
FDA Quality System Regulation – 21 CFR 820
QMSR CentralFDA Quality System Regulation – 21 CFR 820 21 CFR 820, also known as the Quality System Regulation (QSR),...
Edwards EVOQUE Tricuspid Valve Replacement System
Edwards EVOQUE Tricuspid Valve Replacement System In a groundbreaking move, the FDA has recently approved the Edwards...
Device Overview – Spinal Cord Stimulation Systems
What Is an SCS System? A spinal cord stimulation (SCS) system is a medical device used to manage chronic pain by...
Welcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
Our goal is to provide organized, clearly written information from regulatory affairs and consumer perspectives.
- Key information from the Food and Drug Administration (FDA), the federal regulatory agency responsible for providing oversight over the industries and assuring the safety and efficacy of their products.
- Regulatory services for compliance, market access, and crisis management
- Information about innovation, including new products cleared for use in the U.S. market.
- News stories with topics ranging from product issues to market trends.
Perhaps most importantly, we will strive to maintain vigilance over product issues and their impacts. Check back here for consumer news, product alerts, and current litigation.
Medical Devices
Pharma