News Medicine / Pharmaceutical


Selected News

NIST Standard Enables Accurate Dosage of New Anticancer Drugs
NIST Standard Enables Accurate Dosage of New Anticancer Drugs
The National Institute of Standards and Technology (NIST) has developed the first U.S. standard for measuring the radioactivity of actinium-225, a key ingredient in a new class of anticancer drugs.
Verne Health Earns Triple Certification for Information Security and Quality
Verne Health Earns Triple Certification for Information Security and Quality
Dutch healthcare technology company Verne Health, developer of the Verne EPD Platform for healthcare professionals and hospitals,
Consultation Open on Safe Handling of Sterile Medical Equipment in Norway
Consultation Open on Safe Handling of Sterile Medical Equipment in Norway
Standard Norway has opened a consultation on a new technical specification that sets clear requirements for storing, handling, and transporting sterile medical equipment in Norwegian healthcare services.
Russia Now Requires Local Representative for Foreign Medical Device Registration
Russia Now Requires Local Representative for Foreign Medical Device Registration
Foreign manufacturers with medical devices registered in Russia must appoint a Russian Authorized Representative (RUS REP) or update existing representative details by August 31, 2025.
Public Consultation Opens in Norway on Patient Pathway Standard for Diagnostic Imaging
Public Consultation Opens in Norway on Patient Pathway Standard for Diagnostic Imaging
A draft Norwegian version of a new European standard for the patient pathway in diagnostic imaging is now open for public consultation until May 1.
UK to Tighten Post-Market Rules for Medical Devices Starting June 2025
UK to Tighten Post-Market Rules for Medical Devices Starting June 2025
The UK’s new Post-Market Surveillance (PMS) regulations for medical and in vitro diagnostic devices will come into force on June 16, 2025.
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.
Standard Norway Seeks Experts for European Healthcare Standards Group
Standard Norway Seeks Experts for European Healthcare Standards Group
Standard Norway is inviting 4-6 professionals to join the newly established CEN/CENELEC SAG Healthcare standards group, which aims to identify and address standardization needs in the healthcare sector.
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).

Global News

MSC Opens Review Of Chain Of Custody Standard For Public Consultation
MSC Opens Review Of Chain Of Custody Standard For Public Consultation
The Marine Stewardship Council (MSC) has launched a public consultation on proposed revisions to its Chain of Custody Standard, inviting stakeholders across the seafood supply chain to provide feedback until May 30, 2026.
Call For Food Sector Stakeholders To Influence ISO 22000 Revision Through National Committees
Call For Food Sector Stakeholders To Influence ISO 22000 Revision Through National Committees
Food sector stakeholders who apply ISO 22000 in practice have the opportunity to influence its revision by bringing real-world experience into the process.
AutoCarbon Certification Scheme Due in 2027 As Pilot Phase Begins
AutoCarbon Certification Scheme Due in 2027 As Pilot Phase Begins
The International Automotive Oversight Bureau (IAOB) has announced AutoCarbon,
ISO 14064-5 Introduces Guidance For Remote Verification Of Greenhouse Gas Data
ISO 14064-5 Introduces Guidance For Remote Verification Of Greenhouse Gas Data
The International Organization for Standardization (ISO) has introduced ISO 14064-5, which provides guidance on how to carry out verification and validation of greenhouse gas (GHG) data using remote techniques in digital environments.
ISO 9002 Revision Moves To Draft International Standard Stage
ISO 9002 Revision Moves To Draft International Standard Stage
The revision of ISO 9002 has entered the Draft International Standard (DIS) stage, with ISO/TC 176/SC 2, the ISO subcommittee responsible for quality systems, advancing the project into formal consultation. 
ISO 37304 Compliance Management Certification Standard Advances to Final Draft Stage
ISO 37304 Compliance Management Certification Standard Advances to Final Draft Stage
The International Organization for Standardization (ISO) has advanced ISO 37304 to the final draft international standard (FDIS) stage.
One Vote Tips Toward New Edition Of ISO/IEC 17065 Over Amendment
One Vote Tips Toward New Edition Of ISO/IEC 17065 Over Amendment
One vote has tipped the decision toward publishing a new edition of ISO/IEC 17065 instead of issuing a separate amendment, following a closely split ballot within the International Organization for Standardization (ISO).
Is ISO 25500 a Solution to Supply Chain Data Challenges?
Is ISO 25500 a Solution to Supply Chain Data Challenges?
ISO 25500, a draft series of standards from the International Organization for Standardization (ISO), is presented by the Electronic Commerce Code Management Association (ECCMA) as a possible way to address long-standing problems with unreliable data across global supply chains.
IFS Updates Food, Logistics, Broker And Pacsecure Doctrines To Clarify Certification Rules
IFS Updates Food, Logistics, Broker And Pacsecure Doctrines To Clarify Certification Rules
The International Featured Standards (IFS) has published updated doctrine documents for its current standards covering food production, logistics, brokerage, and packaging materials, clarifying how certification requirements should be applied without revising the standards themselves.
PAS 25535 on Sustainability in Asset Management Reaches Draft Stage
PAS 25535 on Sustainability in Asset Management Reaches Draft Stage
PAS 25535, a specification focused on integrating sustainability into asset management systems, has reached the committee draft stage within the International Organization for Standardization (ISO), marking the close of its initial comment period. 
ISO 9001 Revision Moves to FDIS Stage as Early Analysis Questions Scope of Changes
ISO 9001 Revision Moves to FDIS Stage as Early Analysis Questions Scope of Changes
The International Organization for Standardization (ISO) has confirmed that the revision of ISO 9001 has entered the Final Draft International Standard (FDIS) stage, marking the last step before publication.
DIN to Lead ISO IEC Joint Technical Committee 5 on Digital Product Passport Standards
DIN to Lead ISO IEC Joint Technical Committee 5 on Digital Product Passport Standards
Following an initiative by the German Institute for Standardization (DIN) and the German Commission for Electrical, Electronic & Information Technologies (DKE),
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