News Medical Products & Pharmaceuticals


Selected News

NHSGGC Biorepository Becomes First in UK to Earn UKAS Accreditation Under ISO 20387
NHSGGC Biorepository Becomes First in UK to Earn UKAS Accreditation Under ISO 20387
NHS Greater Glasgow and Clyde's (NHSGGC) Biorepository is the first facility in the UK to receive UKAS accreditation under ISO 20387:2018, the international standard for biobanking.
NEN Seeks Dutch Experts for In Vitro Diagnostics Standards Committee
NEN Seeks Dutch Experts for In Vitro Diagnostics Standards Committee
The Netherlands Standardization Institute (NEN) is seeking Dutch experts to join its In Vitro Diagnostics (IVD) standards committee.
NSAI Seeks Feedback on Potential Revisions to ISO 13485 for Medical Device Quality
NSAI Seeks Feedback on Potential Revisions to ISO 13485 for Medical Device Quality
The National Standards Authority of Ireland (NSAI) is inviting users of ISO 13485:2016 to share their input on possible revisions through a survey.
NEN Initiates Development of Sustainability Guidelines for Medical Devices
NEN Initiates Development of Sustainability Guidelines for Medical Devices
In April 2025, the Netherlands Standardization Institute (NEN) will begin creating a Dutch Practical Guideline (NPR) focused on the sustainability of medical devices.
Medical Device Industry at Midpoint in Transition to FDA’s ISO 13485-Based QMSR
Medical Device Industry at Midpoint in Transition to FDA’s ISO 13485-Based QMSR
A year ago, the FDA adopted ISO 13485 into its Quality System Regulation, rebranding it as the Quality Management System Regulation (QMSR).
How EU’s Unique Device Identification Enhances Medical Device Safety
How EU’s Unique Device Identification Enhances Medical Device Safety
The European Medical Device Regulation (EU) 2017/745 (MDR) requires all medical device manufacturers to assign a Unique Device Identification (UDI) to their products.
Dutch Standard on Ultraviolet Sterilization of Medical Devices Open for Comments
Dutch Standard on Ultraviolet Sterilization of Medical Devices Open for Comments
The The Dutch standardization body (NEN) is inviting comments on its draft standard, NEN 8281.
Fourth Edition of Swedish Handbook for Medical Gas Facilities Published
Fourth Edition of Swedish Handbook for Medical Gas Facilities Published
The Swedish Standards Institute (SIS) has released the fourth edition of SIS Handbook 370: Safety Standard for Medical Gas Facilities.
AFNOR can now issue CE Marking certificates for Medical Devices. Looking for Auditors
AFNOR can now issue CE Marking certificates for Medical Devices. Looking for Auditors
AFNOR Certification is actively seeking auditors specialized in medical device compliance to help meet a growing need for CE marking services.
First Products and Test Facilities Certified Under New IEEE Medical Device Cybersecurity Program
NHS Requires Antibiotic Suppliers to Meet New AMR Certification Standard
NHS Requires Antibiotic Suppliers to Meet New AMR Certification Standard
The NHS is stepping up its fight against superbugs by setting a new standard for antibiotic suppliers.

Global News

21st International Standards Olympiad Held in Korea
21st International Standards Olympiad Held in Korea
The 21st International Standards Olympiad brought together 105 middle-and high-school students from 11 countries in the Republic of Korea for a three-day competition and hands-on experience with international standardization.
ISO Environmental Management Committee Seeks Global Input for 2027-30 Plan
ISO Environmental Management Committee Seeks Global Input for 2027-30 Plan
The International Organization for Standardization (ISO) Technical Committee 207 (ISO/TC 207), Environmental management, has launched a global consultation to help set its priorities for 2027-30.
DIS Ballot for ISO 30401 Knowledge Management Revision Closes September 17
DIS Ballot for ISO 30401 Knowledge Management Revision Closes September 17
ISO 30401, the international standard for knowledge management systems, is currently at the Draft International Standard (DIS) stage, with voting on the proposed second edition due to close September 17, 2026.
IFS Publishes PPWR White Paper and Launches Self-Assessment as EU Rules Take Effect
IFS Publishes PPWR White Paper and Launches Self-Assessment as EU Rules Take Effect
International Featured Standards (IFS) has published a new PPWR white paper and launched a self-assessment tool as the first requirements of the European Union’s Packaging and Packaging Waste Regulation (PPWR) took effect on August 12, 2026.
ISO 22000 Draft Approved With 98% Support, Comments Review Set for November
ISO 22000 Draft Approved With 98% Support, Comments Review Set for November
The revision of ISO 22000, the international standard for food safety management systems, has cleared its Draft International Standard (DIS) ballot with 98% positive votes.
ISO Approves Blockchain-as-a-Service Standard Project
ISO Approves Blockchain-as-a-Service Standard Project
The International Organization for Standardization (ISO) has approved ISO 25904, a new standard project to establish a common technical framework and functional requirements for Blockchain-as-a-Service (BaaS) platforms.
IATF 16949 Second Edition Expected in Mid-2027 With Five Priorities Set
IATF 16949 Second Edition Expected in Mid-2027 With Five Priorities Set
IATF 16949 is expected to reach its second edition in mid-2027, with five priorities set for the revision.
GHG Protocol Aligns Scope 2 and AMI Development for Future Joint ISO Standard
GHG Protocol Aligns Scope 2 and AMI Development for Future Joint ISO Standard
The Greenhouse Gas Protocol (GHG Protocol) the results of its public consultation on the update to its Scope 2 Guidance and released preliminary feedback on the development of its Actions and Market Instruments (AMI) standard.
Risk Management Guidance for AI-Powered Medical Devices: First Edition of ISO/TS 24971-2 Released
Risk Management Guidance for AI-Powered Medical Devices: First Edition of ISO/TS 24971-2 Released
ISO has released the first edition of ISO/TS 24971-2:2026, providing guidance on applying the ISO 14971 risk management process to machine learning-enabled medical devices (MLMDs).
Revised ISO 19008 Expands Cost Coding System to Lower Carbon Energy
Revised ISO 19008 Expands Cost Coding System to Lower Carbon Energy
ISO 19008 has been revised to extend its common system for organizing and comparing cost data to lower carbon energy as well as oil and gas.
GLOBALG.A.P. Farm Assurance and Social Practice Standards Set for September Update
GLOBALG.A.P. Farm Assurance and Social Practice Standards Set for September Update
Agraya has announced that it will publish GLOBALG.A.P. Integrated Farm Assurance (IFA) v6.1 Smart and GLOBALG.A.P. Risk Assessment on Social Practice (GRASP) v2.1 on September 1, 2026.
IEC 63223-2 Sets Risk-Informed Decision-Making (RIDM) Process for Power Network Assets
IEC 63223-2 Sets Risk-Informed Decision-Making (RIDM) Process for Power Network Assets
The International Electrotechnical Commission (IEC) has published IEC 63223-2:2026, introducing a structured risk-informed decision-making (RIDM) process for managing existing assets in power networks.
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