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FDA Aligns U.S. Device Rules With ISO 13485, Replaces QSR With QMSR
The U.S. Food and Drug Administration (FDA) has replaced its long-standing Quality System Regulation (QSR) with the new Quality Management System Regulation (QMSR), changing the legal framework for quality management in the U.S. medical device sector.
NEN Seeks Experts for Clinical Research Standards Committee
The Netherlands Standardization Institute (NEN) is inviting experts to join its Clinical Research standards committee to help shape international standards for clinical investigations of medical devices.
Clearlab Earns MDSAP, ISO 13485 and EU MDR Certifications for Contact Lenses
Clearlab, a manufacturer of vision correction products and lens care solutions, has obtained combined certification under the Medical Device Single Audit Program (MDSAP), ISO 13485, and the European Union Medical Device Regulation (EU MDR).
EU Medical Device Database EUDAMED Opens First Mandatory Modules
The European Commission has published the first four functional modules of EUDAMED, the EU database for medical devices and in vitro diagnostic devices.
Italy Launches Accreditation for ISO 7101 Healthcare Quality Systems
Italy has opened accreditation for certification bodies that audit healthcare organizations against UNI ISO 7101:2024, the standard for quality management in health services.
IEI Secures TFDA QMS Approval and ISO 13485 Certification
IEI Integration Corp, a Taiwan-based provider of medical and industrial computing systems,
NEN Sets Initial Scope For New Guideline On Sustainable Medical Devices
The Netherlands Standardization Institute (NEN) has set the initial scope for developing a new Dutch Practice Guideline (NPR) on sustainability in medical devices.
Mexico Recognizes MDSAP as Equivalent to National Medical Device GMP
Mexico has issued a new interpretation rule for the NOM-241-SSA1-2025 standard on good manufacturing practices (GMP) for medical devices, confirming that
Dutch In Vitro Standards Committee Presents Broad Agenda for New Laboratory Standards
The Dutch In Vitro Diagnostics Standards Committee is driving a wide range of international work on new laboratory and diagnostic standards, reflecting the rapid rise of digital tools, artificial intelligence, and smarter testing systems.
Standard Norway to Establish National Committee on Medical Device Standards
Standard Norway (SN) is creating a new national mirror committee, SN/K 113, to contribute to international standardization on quality management for medical devices.
Sweden Moves to Standardize Medicine Dispenser APIs
Sweden has launched work on a national standard for Application Programming Interfaces (APIs) used in automated medicine dispensers.
Serbian Pharma Conference Explores Digital Transformation of GxP Activities
The Chamber of Commerce and Industry of Serbia (PKS) hosted a professional conference on October 30 focusing on the digitalization of GxP (Good Practice) activities across the supply chain for human medicines.Global News
Public Consultation Opens on ISO 14060, First International Standard for Net Zero Alignment
ISO 14060, the first international standard for net zero alignment, has entered public consultation.
EU Approves EN ISO 15223-1 for Medical Device and IVD Labeling
The European Commission (EC) has approved EN ISO 15223-1, the standard used for symbols on medical device and in vitro diagnostic (IVD) labeling, for use in demonstrating compliance with EU requirements for these products.
GFSI Seeks Feedback on JFSM Recognition Under Benchmarking Requirements v2024
The Global Food Safety Initiative (GFSI) has opened a public stakeholder consultation on the Japan Food Safety Management Association (JFSM) application for recognition under GFSI Benchmarking Requirements Version 2024.
Chery Added as IATF's Third Asian Automotive Group Member
The International Automotive Task Force (IATF) has approved the addition of Chery Automobile, as a new member of IATF AISBL, making it the third Asian automotive group represented in the organization.
IFS Announces June Release of Progress Logistics Version 2
IFS will publish IFS Progress Logistics version 2 at the end of June, updating the program that helps companies prepare for IFS Logistics certification.
Third Cohort of Environmental Management Youth Leadership Group Kicks Off
The third cohort of the ISO Environmental Management (ISO/TC 207) Youth Leadership Group (YLG 3.0) has held its kick-off meeting, bringing together more than 45 participants from around 30 countries.
ISO 9606 Requirements for Welder Qualification Under Revision
The International Organization for Standardization (ISO) is revising ISO 9606, the international standard for qualification testing of welders performing fusion welding.
ISO 9001 Auditing Practices Group Releases First AI-Focused Guidance
The ISO 9001 Auditing Practices Group (APG) has published new guidance on auditing quality management systems that use artificial intelligence, marking the group's first publication dedicated specifically to AI.
ISO 10993-6 Standard for Implantation Testing Updated
The International Organization for Standardization (ISO) has published a revised edition of ISO 10993-6, expanding guidance for implantation studies used in the biological evaluation of medical devices.
All 12 Recognized Food Safety Program Owners Apply for GFSI Version 2024 Recognition
The Consumer Goods Forum's Global Food Safety Initiative (GFSI) has confirmed that all 12 previously recognized Certification Program Owners (CPOs) have applied for recognition against the GFSI Benchmarking Requirements Version 2024.
ISO 14002-3 Climate Guidance Advances to Final Draft Stage
ISO 14002-3, a guidance standard for managing climate-related issues within ISO 14001 environmental management systems, has advanced to the Final Draft International Standard (FDIS) stage.
