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ISO/TS 23485 Nears Draft Technical Specification Stage Following Review of 300 Comments
June 16, 2026
Norway Reestablishes Medical Device Standards Committee, Invites New Members
June 4, 2026
TÜRKAK Revises Proficiency Testing Procedure, Issues New Subfield List
May 13, 2026
North-West Tuscany Offers Grants For Certification Up To 5,000 Euros
April 29, 2026
China Tightens GMP Rules For Medical Device Manufacturers Effective November 2026
April 9, 2026
FDA Schedules Town Hall On Risk Based Inspections Under New QMSR Framework
March 19, 2026
IMDRF Playbook Guides Global Use Of Shared Medical Device Regulatory Reviews
March 17, 2026
FDA Shifts Medical Device Inspections To Lifecycle-Based QMS Oversight
March 12, 2026
FDA Aligns U.S. Device Rules With ISO 13485, Replaces QSR With QMSR
February 5, 2026
Clearlab Earns MDSAP, ISO 13485 and EU MDR Certifications for Contact Lenses
February 4, 2026
IEI Secures TFDA QMS Approval and ISO 13485 Certification
November 26, 2025
Mexico Recognizes MDSAP as Equivalent to National Medical Device GMP
November 19, 2025
ISO 13485 Application Guide, TS 23485, Under Way After Stand
November 18, 2025
Standard Norway to Establish National Committee on Medical Device Standards
November 12, 2025
ISO 13485 Stays Unchanged as Revision Committee Rejects Anne
November 5, 2025
ISO Survey Finds Italy Among Global Leaders in Key Management System Certifications
October 22, 2025
Medsalv Achieves ISO 13485 Certification in New Zealand and Australia
September 17, 2025
FDA Shift to ISO 13485 Makes Live Quality Management System Essential for
August 6, 2025
ISO 13485 Under Review as Industry Prepares for Potential Re
June 25, 2025
Digital Transformation and Smart Standards Take Center Stage in USNC Current Spring 2025 Edition
June 12, 2025
Russia Now Requires Local Representative for Foreign Medical Device Registration
May 21, 2025
NSAI Seeks Feedback on Potential Revisions to ISO 13485 for Medical Device Quality
March 12, 2025
European Report Sets Framework for Sustainable AI Implementation
March 10, 2025
Medical Device Industry at Midpoint in Transition to FDA’s ISO 13485-Based QMSR
February 24, 2025
BSI Introduces Digital Seal for Three Types of Medical Device Certificates
November 26, 2024
AFNOR can now issue CE Marking certificates for Medical Devices. Looking for Auditors
October 31, 2024
How 'As Appropriate' Creates Flexibility in ISO 13485
June 24, 2026
Early Regulatory Strategy Can Shape MedTech Startup Growth
May 27, 2026
Closing CAPAs Without Effectiveness Checks Fails to Prove Issues Are Fixed
May 6, 2026
Real-World Practice Shapes Root Cause Analysis Beyond ISO 13485 Training
April 22, 2026
Transition from ISO 9001 to ISO 13485 Requires Deep System Changes
April 8, 2026
From Five Audits to One: How MDSAP Simplifies Global Medical Device Compliance
April 1, 2026
The High Cost Of False Security In ISO 13485
March 25, 2026
Proposed Framework Helps Navigate Maze Of Medical Device Standards
March 18, 2026
ISO 13485 Alone Does Not Make You IVDR Ready
February 25, 2026
Quality Leaders Must Decide Which Issues Deserve A CAPA
February 18, 2026
How To Get Regulatory Standards For Free
February 11, 2026
Five Major Auditor Challenges Accredited Certification Bodies Face
How EN 18286 Guides Quality Management Compliance Under EU AI Act
How ISO 13485, ISO 14971 and IEC Standards Combine To Build Safe
Practical Tips on Making Quality Assurance Work
May 27, 2025
The Compliance Puzzle: How Standards and Regulations Fit Together
April 15, 2025
Medical Device QMS Success Depends on Knowing ISO 13485 Clause Differences
April 1, 2025
Tips for Gaining Full Management Commitment to Quality Systems
March 26, 2025
Avoiding Common CAPA Mistakes in Medical Device Quality Management
December 24, 2024
Licensing or Accreditation: The Crucial Choice for New Ventures in Pharma and Medical Devices
September 4, 2024
Efficient Supplier Management for Medical Devices Manufacturers
August 5, 2024
CE Marking for Medical Devices
...red before the CE mark can be affixed. Difference between ISO 13485 and CE marking It is important to distinguish bet...
ISO 13485 - Medical Devices Quality Management Systems
...ISO 13485 is an international standard that specifies requir...
Buck doo
...s: ISO 9001, ISO 14001, ISO 27001, ISO 50001, ISO 45001 and ISO 13485. BUCK has been operating in accordance with the IS...
Altagena Consulting
...et must comply with the EU Medical Device Regulation (MDR), ISO 13485 as standard for quality management system exclusev...
