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.

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.

CEN Launches Development of EN 17483-5 on Health Security Services

The European Committee for Standardization (CEN) has begun work on EN 17483-5, a new standard focusing on health security services for the healthcare sector.

ISO and IEC Update AI Rules for Standards Development

ISO and IEC have published updated guidance on the use of artificial intelligence in technical committees, defining how AI may be used during the development of international standards. 

BRCGS Updates Packaging Materials Issue 7 Requirements for GFSI Benchmarking 2024

BRCGS has updated the requirements for its Packaging Materials Issue 7 certification scheme to meet the GFSI Benchmarking Requirements 2024.

SIS Opens Draft ISO 9002 for Public Comment

The Swedish Institute for Standards (SIS) has opened public access to the draft version of ISO 9002, allowing organizations and quality professionals to read and comment on the official guidance for applying ISO 9001 before the document is finalized.

Busy Week Brings Four Automotive Quality Updates

It has been a busy week for automotive quality, with four significant updates released for the sector.

ISO 33400:2026 Sets International Vocabulary for Reference Materials

The International Organization for Standardization (ISO) has published ISO 33400:2026, updating the international vocabulary for reference materials (RM) and certified reference materials (CRM).

TIC Council Backs ISO 14019 as Framework for Sustainability Assurance

The International Association for Testing, Inspection and Certification (TIC Council) has published a paper urging policymakers to recognize the ISO 14019 series as the framework for sustainability assurance,

IFS Updates Progress Scoring Guide for Food and Logistics Programs

International Featured Standards (IFS) has updated its Progress Scoring System brochure following the recent launch of IFS Progress Logistics 2.

CQI Announces International Quality Awards 2026 Winners

The Chartered Quality Institute (CQI) announced the winners of the International Quality Awards 2026 during the Quality Live event in London on June 25,

IAQG Centralizes Aerospace Auditor Authentication

The International Aerospace Quality Group (IAQG) has centralized the authentication of aerospace quality management system auditors, replacing the previous network of independent Auditor Authentication Bodies (AABs).

FSC Revised Trademark Standard Takes Effect

The Forest Stewardship Council (FSC) has launched a new online training course to support implementation of its revised trademark standard, FSC-STD-50-001 V3-0, which takes effect on July 1, 2026. 

SIS Offers Free Access to ISO 45001 Draft

The Swedish Institute for Standards (SIS) has made the proposed second edition of ISO 45001 - draft available for free download and public review,

ISO/DIS 9002 Ballot Opens for Comment

The International Organization for Standardization (ISO) has released ISO/DIS 9002 for ballot, opening the international comment period on the revision of the guidance standard for applying ISO 9001.