Industry Update: Quality Management System Regulation (QMSR)
Explore FDA’s new QMSR aligning with ISO 13485, simplifying compliance for device makers. Get ready with NAMSA’s expert transition guidance.
Category: Quality
Industry Update: Proposed FDA Ruling of Changes to 21 CFR part 820-QSR
On February 23, 2022 the U.S. Food and Drug Administration (FDA) published the proposed ruling of changes to the current 21 CFR part 820 – Quality System Regulation (QSR) and upon finalization, will be referred to as the ‘Quality Management System Regulation (QMSR).’ This ruling, among other changes, incorporates a significant shift incorporating by reference, the Quality Management System requirements of ISO 13485:2016.
Industry Update: U.S. FDA Quality Management System Regulation
On March 2, 2022, the U.S. Food and Drug Administration (FDA) Device Good Manufacturing Practice Advisory Committee will meet to discuss and make recommendations on the current good manufacturing practice requirements for medical devices as part of an ongoing effort to more closely align U.S. Quality System requirements to other international standards.
Mapping QMS to EU IVDR Requirements: 3 Key Takeaways to Effectively Strategize QMS Implementation
The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) 2017/745 has introduced a number of Quality Management System (QMS) requirements for In Vitro Diagnostic (IVD) manufacturers.
EU IVDR: Understanding the New QMS Requirements
On 26 May 2017, the European Commission (EC) introduced the In Vitro Diagnostic Regulation (IVDR 2017/746), which replaces the current In Vitro Diagnostic Directive (IVDD 98/79/EC) and introduces major changes for IVD manufacturers throughout the European Union (EU). The IVDR: The Fantastic 4 (Systems) or 1 System for All? The IVDR clearly lays out that … Continued
Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard
Risk management is an important lifecycle product development requirement for all medical device organizations when developing, manufacturing, and commercially distributing medical products. To appropriately address issues of potential risk within the European Economic Area (EEA), manufacturers must utilize the harmonized standard, EN ISO 14971:2012, to meet regulatory requirements. However, EU device manufacturers often struggle to … Continued
ISO 13485:2016 – Effective Preparation and Implementation of Medical Device Quality Management Systems
Introduction The International Organization of Standards (ISO) is a worldwide federation of member bodies within a specific technical skill set that is responsible for the draft and release of global medical device regulations. In 1996, the ISO established guidance ISO 13485:2003 under the jurisdiction of the ISO / International Electrotechnical Commission (IEC) Directive, Part 1 … Continued
The Importance of Human Factors & Usability Engineering in Medical Devices
Human factors principles have long been applied in high-hazard industries such as aerospace, nuclear, petrochemical, energy and transport in an effort to minimize potential risks. Increasingly, human factors in the life science industry have become recognized as an important topic. While human factors engineering was previously only accepted as necessary for electro-medical devices with complex … Continued
Focus on Japan Series: Part IV – Streamlining the Quality Management System Approval Process
Like several other geographies throughout the globe, the Country of Japan has its own Quality Management System (QMS) Ordinance for medical devices, which subsists of ISO 13485 requirements and additional country-specific standards. All medical products marketed and sold in Japan must be manufactured in accordance with these QMS requirements in mind. It is important to … Continued