Medical device examples
A sampling of the types of medical devices on the U.S. market, from electrical stimulators to CPAP and BiPAP machines. Most of these are U.S. Class II devices that require a cleared premarket notification (510(k)) to enable them to be marketed in the United States. And most of them have had a product safety recall or correction.
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Medical Device Headlines
ISO 9000 Clause 3 Definitions
Establishing a Common Language for Quality Management Systems ISO 9000:2015 serves as the cornerstone of the ISO 9000 family of standards, providing essential terminology and principles for quality management systems (QMS). It establishes a shared language that...
QMSR Integration
QMSR Integration The integration of FDA Quality System Regulation (QSR) requirements into ISO 13485:2016 provides a unified approach for medical device manufacturers to align with global standards while meeting U.S. regulatory requirements. The FDA's Quality...
QMSR Definitions and Vocabulary
QMSR Definitions The transition to the FDA’s new Quality Management System Regulation (QMSR) brings updated terminology and definitions that are crucial for ensuring compliance. Whether you’re new to regulatory requirements or transitioning from the Quality System...
QMSR for Small Manufacturers
Streamlined FDA QMSR Consulting for Small Manufacturers Navigating the FDA's new Quality Management System Regulation (QMSR) can be a challenge for small medical device manufacturers, but compliance doesn’t have to be overwhelming. At Medical Devices and Pharma (MDP),...
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
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 on that day will replace the current Quality System Regulation (QSR, 21...
FDA QMSR: Overview of the ISO 13485 Standard
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 on that day will replace the current Quality System Regulation (QSR, 21...
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...