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    News and Commentary on ISO Management System Standards

    19 Jun 2025

    FDA QMSR and ISO 13485 – what you need to know

    ISO 13485

    On 02-Feb-26, the FDA Final Rule, amending the Current Good Manufacturing Practice (cGMP) requirement of the Quality System Regulation (QSR) of medical device manufacture, comes into force. The amendments incorporate by reference (and so align more closely with) the international standard ISO 13485:2016, Medical Devices - Quality Management Systems - Requirements for regulatory purposes. The new ...
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    14 May 2025

    ISO 13485: Critical Subcontractors & Crucial Suppliers

    ISO 13485

    EU Regulations, EN Standards, Notified Body activities (including Surprise/Unannounced Audits), UK Regulations post-Brexit, and MDSAP – all are changes that will impact your company’s Medical Device Management System (MDMS). What strategy should you, as a supplier to the sector, adopt to implement the ISO 13485 Standard and to comply with the other applicable standards and requirements? Your ISO ...
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    29 Apr 2025

    Unannounced Audits by Notified Bodies: What you need to Know

    ISO 13485

    If your company supplies components or materials to an EU medical device manufacturer, here is the information you need to be aware of, as outlined in the ISO 13485 Regulations. And it's about unannounced audits of your business by Notified Bodies.
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    22 Apr 2025

    The IAF Logo on your ISO 13485 Certificate?

    ISO 13485

    The IAF MLA mark is now available to all CABs accredited by The European Cooperation for Accreditation (EA) Members and is recognized and accepted by all 563 IAF members from 81 countries.
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    22 Apr 2025

    IVDR Transition Deadline extended up to 2027

    ISO 13485

    Despite repeated statements that the IVDR deadline of 26 May 2022 would not be extended, that is precisely what the European Commission did. Whilst just a proposal at the moment, ratification by the European Parliament and Council is just a formality and formal adoption by publication in the Official Journal of the European Union will follow.
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    21 Dec 2024

    ISO 13485 Certification in the Medical Device Supply Chain

    ISO 13485

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    24 Oct 2024

    Medical Devices: Managing Residual Risk and Risk Tolerance

    ISO 13485

    Managing residual risk and understanding risk tolerance are crucial aspects of ISO 13485 compliance. ISO 13485:2016 is an international standard that outlines the requirements for a quality management system (QMS) in the medical device industry. Clause 7.1 requires risk management in relation to operations and, in a note (not, therefore, a requirement), refers to ISO 14971. How, then, should you ...
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    08 Aug 2024

    ISO 13485 Risk Evaluation for Medical Devices explained

    ISO 13485

    There are two distinct and different requirements in ISO 13485:2016 for the management of risk. From Dr John FitzGerald: Misinformation about risk management is already too easy to find regarding the adoption of ISO 13485 in the FDA's QMSR regulations, which will come into force in February 2026. If you follow the advice of these self-appointed experts, you will likely become confused and perhaps ...
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    18 Jun 2024

    ISO 13485 - What Suppliers to the Medical Device Sector Need to Know

    ISO 13485

    Many organizations with the potential to supply components, packaging, and other goods and services (incl. logistics) to the Medical Device Sector are scared off by talk of CE Marking, Notified Bodies, regulatory inspections, unannounced/surprise audits, and the like. It's all nonsense (well, almost all). You don't believe me? Then read on. There could be a lot of high-margin business that you're ...
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    21 Sep 2023

    PRRC: Are you in breach of the EU MDR and IVDR Requirement?

    ISO 13485

    The EU MDCG 2019-7 provides guidance on "Persons Responsible for Regulatory Compliance’ (PRRC). The European Commission (EC) has published MDCG 2019-7, Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC). Meeting the requirements here will challenge SMEs and start-ups, but ...
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