deGRANDSON Global Blog | ISO 13485 (2)

News and Commentary on ISO Management System Standards

24 Oct 2024

Medical Devices: Managing Residual Risk and Risk Tolerance

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 ...

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 ...

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 ...

22 Mar 2023

MDR Transition Deadlines extended to 2028

ISO 13485

But it’s complicated, required deadlines vary by Class and for all devices. You need to take action now or risk having no product to sell.

News and Commentary on ISO Management System Standards

Medical Devices: Managing Residual Risk and Risk Tolerance

ISO 13485 Risk Evaluation for Medical Devices explained

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

MDR Transition Deadlines extended to 2028

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