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Understanding the Gaps and Overlaps Between ISO 13485, EU MDR, and MDSAP
ISO 13485, EU MDR, and MDSAP share significant commonalities in quality management, risk control, post-market surveillance, and documentation practices. However, gaps remain in clinical evaluation, UD... ...more
ISO13485 Certification
October 22, 2025•6 min read
Case Study: Establishing ISO 13485 and ISO 14971 Compliance
Case Study: Establishing ISO 13485 and ISO 14971 Compliance in a New Medical Device Manufacturing Facility ...more
ISO13485 Certification
September 23, 2025•5 min read
ISO13485:2016 – Quality Management Systems for Regulatory Purposes
ISO13485:2016 – Quality Management Systems for Regulatory Purposes ...more
ISO13485 Certification
July 14, 2025•6 min read
Identifying Gaps in Your GMP and ISO 13485 Compliance
Identifying Gaps in Your GMP and ISO 13485 Compliance ...more
ISO13485 Certification ,GMP
June 02, 2025•6 min read
Recent Developments for ISO 13485
Recent Developments for ISO 13485 ...more
ISO13485 Certification ,GMP &Medtech
January 01, 2025•3 min read
Compliance Readiness Assessment for GMP and ISO 13485
Compliance Readiness Assessment for GMP and ISO 13485 ...more
ISO13485 Certification ,GMP
December 02, 2024•5 min read
A Strategic Approach for Timely Market Entry
A Strategic Approach for Timely Market Entry ...more
ISO13485 Certification ,GMP
November 12, 2024•5 min read
Site Licensing & Accreditation: Ensuring Compliance
Site Licensing & Accreditation: Ensuring Compliance Through GMP, ISO 13485, and ISO 17025 ...more
ISO13485 Certification ,GMP
October 14, 2024•6 min read
Get a Free Compliance Readiness Assessment from Quality Systems Now
Get a Free Compliance Readiness Assessment from Quality Systems Now ...more
ISO13485 Certification ,Quality Culture &GMP
September 23, 2024•4 min read
Establishing Organisational Audit Preparedness
Establishing Organisational Audit Preparedness pharmaceuticals and medical devices ...more
ISO13485 Certification ,Good Manufacturing Practices Quality Culture &QMS
August 27, 2024•5 min read
Difficulty in maintaining control over compliance with GMP or ISO13485?
Difficulty in Maintaining Control Over Compliance with GMP or ISO 13485: A Comprehensive Analysis ...more
ISO13485 Certification ,ISO Recommendations &GMP
August 23, 2024•7 min read
Training Programs Coupled with QMS Development
Implementing training programs, coupled with QMS development. ...more
ISO13485 Certification ,Quality Training &GMP
July 18, 2024•5 min read
Site licensing or accreditation for Greenfield sites and New Ventures
Site licensing or accreditation for Greenfield sites and New Ventures ...more
ISO13485 Certification ,Good Manufacturing Practices &GMP
July 18, 2024•6 min read
Understanding ISO 13485: Ensuring Quality in Medical Device Manufacturing
ISO 13485 is an international standard that outlines the requirements for a comprehensive quality management system (QMS) for the design and manufacture of medical devices. ...more
ISO13485 Certification ,ISO Recommendations &GMP
June 05, 2024•4 min read
What is ISO13485 Certification?
Critical summary on ISO Certification 13485 ...more
ISO13485 Certification
April 10, 2024•4 min read
Are your document headings 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝘁 𝘁𝗼 𝗜𝗦𝗢 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀?
Document headings are the roadmap to clarity. ...more
ISO Certification 9001 ,ISO13485 Certification ISO Recommendations &Document Writing
September 14, 2023•0 min read