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EU Expands Laboratory Oversight for Highest Risk In Vitro Diagnostic Devices
The European Union (EU) has expanded oversight of Class D in vitro diagnostic medical devices under Regulation (EU) 2017/746, known as the In Vitro Diagnostic Regulation (IVDR).
BIS Seeks Public Feedback on Draft Standards for Medical Devices and Healthcare
The Bureau of Indian Standards (BIS), through its Medical Equipment and Hospital Planning Department,
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.Global News
SMART Initiative Enters Pilot Phase in October, Testing Nine Standards
A pilot of the ISO and IEC SMART standards initiative will begin in October, testing nine selected international standards.
New Net Zero Carbon Cities Standard Project Approved as ISO 37115-2
The International Organization for Standardization (ISO) has approved a proposal for ISO 37115-2, a new standard that will set out principles and fundamentals for net zero carbon cities.
First Edition of ISO 41002 Guides Development of Facility Management Organizations
The first edition of ISO 41002 gives organizations guidance on how to develop and structure their facility management function across strategic, tactical and operational levels.
ISO/DTS 5112 Road Vehicle Cybersecurity Audit Guidance Reaches Final Approval Stage
ISO/DTS 5112, the draft Technical Specification for auditing cybersecurity management systems (CSMS) across the automotive supply chain, has reached the final approval stage.
ISO 37011 Webinars on Purpose-Driven Organizations Set for September 22 and 23
Two international webinars on ISO 37011, the draft guidance standard for purpose-driven organizations, will be held on September 22 and 23 ahead of consultation on the draft beginning September 24, 2026.
ISO 45010 Becomes First International Standard on Menstruation and Menopause at Work
ISO has published ISO 45010, the first International Standard focused on supporting employees experiencing menstruation and menopause at work.
Digital Identity Standards Now Freely Accessible Worldwide
Key ISO and IEC digital identity standards, including the ISO/IEC 18013 and ISO/IEC 23220 series, are now freely accessible worldwide through a new sponsorship model set up by the German Institute for Standardization (DIN) and the OpenWallet Foundation (OWF).
GFSI Opens Consultation on FSSC 22000 Version 7 Against 2024 Benchmarking Requirements
The Global Food Safety Initiative (GFSI) has opened a public consultation on the recently updated FSSC 22000 Version 7 as part of its assessment against the GFSI Benchmarking Requirements Version 2024.
Accreditation Bodies Roll Out ISO 14001 Transition Plans
Accreditation bodies are putting the ISO 14001:2026 transition timetable into practice, with Norwegian Accreditation (NA) among the latest to publish detailed arrangements for certification bodies moving to the revised environmental management systems standard.
ISO Considers Three Tourism Proposals on Restaurant Evaluation, Tourist Guides and AI
Three tourism standardization proposals are now under consideration at the International Organization for Standardization (ISO), covering restaurant evaluation, professional tourist guide services and the use of artificial intelligence with tourism destination data.
ISO 14002-3 Released as Guidance on Climate Change
The International Organization for Standardization (ISO) has released ISO 14002-3:2026, new guidance to help organizations using ISO 14001 address climate change through their environmental management systems.
