Medical device types
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.
Read more about medical devices. If you would like to recommend additional devices to add to this page, please let us know.
Medical Device Headlines
The Role of a Regulatory Professional
510(k) Submissions The New QSMR Regulatory Intelligence RIM Systems Regulatory Competencies Regulatory and Quality Role of Regulatory Professionals: Core Responsibilities Regulatory professionals play a critical role in ensuring that medical devices and pharmaceutical...
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 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 -...
QMSR Design Verification and Validation
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 -...
QMSR Design and Development Reviews
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 -...
QMSR Design and Development – Design Inputs and Outputs
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 -...
QMSR Design and Development Controls
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...
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...