Slavmed Medical Center First in South Caucasus to Earn ISO 7101:2023 Certification

Slavmed Medical Center in Yerevan, Armenia has become the first healthcare provider in the South Caucasus to receive certification for ISO 7101:2023,

Hong Ngoc Hospital Gene Center Accredited to ISO 15189 for Medical Labs

The National Accreditation Bureau (BoA) has accredited the Gene Center at Hong Ngoc General Hospital - Phuc Truong Minh under ISO 15189,

DAkkS Completes ISO 15189 Transition With All Medical Labs in Germany Retaining Accreditation

The Deutsche Akkreditierungsstelle (DAkkS), Germany’s national accreditation body, has successfully completed the nationwide changeover to the revised DIN EN ISO 15189 standard for medical laboratories.

FDA Shift to ISO 13485 Makes Live Quality Management System Essential for Medical Devices

Starting February 2, 2026, the U.S. Food and Drug Administration (FDA) will align its Quality System Regulation with ISO 13485:2016, making it the foundation for all medical device market submissions.

NATA Publishes Biobanking Guide to Strengthen Trust in Stored Biological Materials

The National Association of Testing Authorities (NATA) has released a new Biobanking Industry Guide to help organizations understand the importance of accreditation in maintaining reliable, high-quality biological materials for long-term research and data use.

Cofrac Updates Accreditation Guides for Pathology and Reproductive Biology Labs

The French Accreditation Committee (Cofrac) has released revised versions of two technical accreditation guides, SH GTA 03 and SH GTA 05, aligning them with the 2022 edition of the standard NF EN ISO 15189, the French version of the standard for quality and competence in medical laboratories.

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

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

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

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

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

The UK’s new Post-Market Surveillance (PMS) regulations for medical and in vitro diagnostic devices will come into force on June 16, 2025.