Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationWelcome 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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The Latest Posts
QMSR Management Responsibility
Transitioning from QSR to QMSR – Management Responsibility The QMSR Management Responsibility requirements bring a more structured, documented, and proactive approach compared to QSR §820.20. While many concepts remain similar, organizations must focus on:✅ Stronger...
QMSR Quality Manual
Why This Matters in the QMSR Transition U.S. Manufacturers Adopting ISO 13485 Will Need a Quality Manual While QMSR does not mandate a Quality Manual, ISO 13485 compliance does—meaning manufacturers aligning with QMSR will likely need to create one. Many U.S. medical...
QMSR Quality Management System Requirements
Overview of QMSR Quality Management System Requirements The QMSR (Quality Management System Regulation) under 21 CFR 820.10 aligns U.S. medical device manufacturers with ISO 13485 while maintaining FDA-specific requirements. This hybrid framework ensures international...
QMSR Clauses 1 and 2 – Scope and Normative References
ISO 13485 Clause 1 and Clause 2 For medical device manufacturers, compliance with ISO 13485:2016 is essential to ensure the quality, safety, and regulatory alignment of their products. The first two clauses of the standard lay the groundwork for understanding its...
Generic Eliquis
Generic Eliquis Editor's note: FDA originally announced the approval of generic equivalents to Eliquis in 2019, and updated that information the next year. We are publishing this information as a response to reader requests for more information about generic Eliquis....
QMSR Design and Development Transfer and Changes
ISO 13485:2016 Clause 7.3 - Design and DevelopmentClause 7.3.1 - GeneralClause 7.3.2 - Design and development planningClause 7.3.3 - Design and development inputsClause 7.3.4 - Design and development outputsClause 7.3.5 - Design and development reviewClause 7.3.6 -...