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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 Design and Development 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...
Affected Regulations and Standards
QMSR-Related Regulations and Standards The transition from the FDA’s Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) marks a significant shift in how medical device manufacturers align with global quality standards. This page...
Request QMSR Information
QMSR Information Request Form Are you ready for the FDA’s transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR)? The new QMSR framework aligns more closely with ISO 13485, bringing significant changes to how medical...
QMSR Purchasing Controls
Comparison of QSR and QMSR requirements for Purchasing Controls Starting on February 2, 2026, most medical device companies who sell their devices in the United States must comply with FDA’s new Quality Management System Regulation (QMSR, 21 CFR 820), which replaced...
QMSR Frequently Asked Questions
Although the FDA has done an excellent job of laying out QMSR requirements and explaining differences between the QSR and the QMSR, there are questions related to the implementation of the new Quality Management System Regulation (QMSR) that need an answer. This page...
EU MDR Compliance Consulting Services
Medical Devices and Pharma offers comprehensive services to help your business meet the stringent requirements of the EU Medical Device Regulation (MDR). Our expertise ensures that your products are compliant, safe, and ready for the European market.At Medical Devices...
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 implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) due to various challenges faced by...
FDA Grants Accelerated Approval to Tarlatamab-dlle
Treatment for lung cancer with progression following platinum-based chemotherapy On May 16, 2024, the Food and Drug Administration (FDA) granted accelerated approval to Imdelltra (tarlatamab-dlle) manufactured by Amgen, Inc. for the treatment of extensive stage small...