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.

Italy Launches Accreditation for ISO 7101 Healthcare Quality Systems

Italy has opened accreditation for certification bodies that audit healthcare organizations against UNI ISO 7101:2024, the standard for quality management in health services.

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.

Serbian Pharma Conference Explores Digital Transformation of GxP Activities

The Chamber of Commerce and Industry of Serbia (PKS) hosted a professional conference on October 30 focusing on the digitalization of GxP (Good Practice) activities across the supply chain for human medicines.

Standardizing Hospital Design Terminology with New UNI 11993

Italy’s national standards body UNI has published UNI 11993, a new standard that defines terminology for hospital and healthcare structures to

CEN Launches Development of EN 17483-5 on Health Security Services

The European Committee for Standardization (CEN) has begun work on EN 17483-5, a new standard focusing on health security services for the healthcare sector.

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 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?

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

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, 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

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

Following an initiative by the German Institute for Standardization (DIN) and the German Commission for Electrical, Electronic & Information Technologies (DKE),

ANSI/TIA-942 Addendum Targets AI Data Center Cooling and High-Density Needs

The Telecommunications Industry Association (TIA) is developing a new addendum to the ANSI/TIA-942 data center standard to address the growing demands of artificial intelligence (AI) infrastructure.

IATF Introduces Mandatory Auditor Training for Corporate Scheme Audits

The International Automotive Task Force (IATF) has approved a new mandatory training module to strengthen how auditors assess organizations certified under corporate audit schemes for IATF 16949.

ISO/TS 19384 Sets First Standard for Digital Service Excellence

The International Organization for Standardization (ISO) has released ISO/TS 19384:2026,

FSSC Issues Five Sector-Specific Guides for Development Program Implementation

The Foundation for Food Safety Certification (FSSC) has published five sector-specific guidance documents to support organizations using the FSSC Development Program,

ISO 14001 Fourth Edition Officially Released

The International Organization for Standardization (ISO) has published ISO 14001:2026, marking the release of the fourth edition of the world’s most widely used environmental management systems standard.