Management Systems World
All on Quality and other Standards in one place since 2010. Now Worldwide.
News Medicine / Pharmaceutical
Please note that you have to be a registered member with paid membership in order to see full articles.
RegisterSelected News
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.Global News
ISO 10993-6 Standard for Implantation Testing Updated
The International Organization for Standardization (ISO) has published a revised edition of ISO 10993-6, expanding guidance for implantation studies used in the biological evaluation of medical devices.
All 12 Recognized Food Safety Program Owners Apply for GFSI Version 2024 Recognition
The Consumer Goods Forum's Global Food Safety Initiative (GFSI) has confirmed that all 12 previously recognized Certification Program Owners (CPOs) have applied for recognition against the GFSI Benchmarking Requirements Version 2024.
ISO 14002-3 Climate Guidance Advances to Final Draft Stage
ISO 14002-3, a guidance standard for managing climate-related issues within ISO 14001 environmental management systems, has advanced to the Final Draft International Standard (FDIS) stage.
ISO/TS 23485 Nears Draft Technical Specification Stage Following Review of 300 Comments
The International Organization for Standardization's (ISO) Technical Committee 210 (ISO/TC 210) is advancing work on ISO/TS 23485,
Global ACI Explains Which IAF and ILAC Documents Remain in Force During Transition
The Global Accreditation Cooperation Incorporated (Global ACI) has published a cross-reference tableshowing the status of former International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) publications.
Standards Behind the FIFA World Cup 2026
As the FIFA World Cup 2026 gets underway across the United States, Canada and Mexico,
CEN and CENELEC Open Nominations for 2026 Standards+Innovation Awards
The 2026 Standards+Innovation Awards are now accepting nominations for individuals and projects that have contributed to standardization through research, innovation and education.
PEFC Launches Project Sourcing Certification for Construction Projects
The Programme for the Endorsement of Forest Certification (PEFC) has launched a new Project Sourcing certification program for the construction sector.
Development Begins on ISO 59001 Circular Economy Management Standard
The International Organization for Standardization (ISO) has begun development of ISO 59001, a future certifiable management system standard for the circular economy.
ISO 32212 Introduces Net Zero Transition Planning Framework for Finance
The International Organization for Standardization (ISO) has published ISO 32212:2026,
ISO 45010 Workplace Menstruation and Menopause Guidance Advances to Final Approval Stage
The International Organization for Standardization (ISO) has advanced ISO 45010, which provides guidance on menstruation and menopause in the workplace, has advanced to the Final Draft International Standard - FDIS stage.
