Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
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A Team-based Approach to an Expedited 510(k)
Getting an expedited 510(k) submission So, you have created a new medical device by following your quality system’s design controls to plan the project, define design inputs, test to verify that outputs meet inputs, and validated your production product. Now what?...
FDA Warning Letter to Olympus Medical Systems
Letter addresses several violations of FDA&C Act On March 15, 2023, the Food and Drug Administration (FDA) issued a Warning Letter to Olympus Medical Systems Corp. The letter addressed several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act)...
Class I Recall for Intra-Aortic Blood Pumps
Datascope/Getinge IABPs May Malfunction Due to Cable Failure The US Food and Drug Administration (FDA) announced yesterday that Datascope/Getinge is recalling certain CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) due to a risk of device malfunction....
Urgent Action Required – Baxter LIFE2000 System
Software issue can cause potential harm or death On March 10, the US Food and Drug Administration (FDA) announced that Baxter International Inc. has issued an urgent medical device correction for its LIFE2000 Ventilation System. An issue with the device’ software may...
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QMSR – Overview of Changes
QMSR Implementation The U.S. Food and Drug Administration (FDA) has introduced significant updates to its regulatory...
Request QMSR Information
QMSR Information Request Form Are you ready for the FDA’s transition from the Quality System Regulation (QSR) to the...
QMSR Purchasing Controls
Comparison of QSR and QMSR requirements for Purchasing Controls Starting on February 2, 2026, most medical device companies...
QMSR Frequently Asked Questions
Although the FDA has done an excellent job of laying out QMSR requirements and explaining differences between the QSR and...
EU MDR Compliance Consulting Services
Medical Devices and Pharma offers comprehensive services to help your business meet the stringent requirements of the EU...
Extensions for EU MDR and IVDR Implementation
Initial EU MDR and IVDR transition periods extended In 2023, the European Union granted an extension for the...
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.
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