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).

Topolšica Hospital Achieves Slovenia's First ISO 7101 Certification

Topolšica Hospital has become the first medical institution in Slovenia to earn the ISO 7101 certification for management systems for quality in healthcare organizations.

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.

ISBIH Translates ISO 15189 Standard for Medical Laboratories

The Institute for Standardization of Bosnia and Herzegovina (ISBIH) has translated the latest edition of the international standard Medical Laboratories—Requirements for Quality and Competence, and issued it as BAS EN ISO 15189:2022.

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.

Netherlands Updates Standard for IT Security in Healthcare

The updated Dutch standard for information security in healthcare is now available on the NEN Connect, the platform of the Netherlands' national standards organization.

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.

EU’s QUANTUM Project Aims to Create a Standardized Health Data Quality and Utility Label

The QUANTUM project is an initiative that aims to create a standardized health data quality and utility label for the secondary use of health data across the EU.

Swedac Conducts First Assessments Under Updated ISO 15189 Standard

The 2022 version of the ISO 15189 standard has been implemented, and Swedac began inspections of medical laboratories against it in January 2024.

Standard for Auditing Healthcare Quality Management Systems Released in Serbian

A new standard specifying competency requirements for auditing and certifying quality management systems in healthcare organizations has been published in Serbian.

Nigeria’s Healthcare Sector Leverages ISO Certifications to Reverse Medical Tourism

Nigeria’s healthcare system is taking strides to retain local patients and curb outbound medical tourism by implementing ISO 9001 Quality Management Systems (QMS) and ISO 15189 for medical laboratory competence.

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.