deGRANDSON Global Blog | ISO 13485 (2)

News and Commentary on ISO Management System Standards

08 Aug 2024

ISO 13485 Risk Evaluation for Medical Devices explained

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 ...

14 Sep 2023

Cybersecurity in Medical Device Management

ISO 13485, ISO 27001

Did you know that cybersecurity is addressed under ISO 13485:2016 Clause 7.3 requirements? Whether you are marketing a Medical Device Software (MDSW) product or a medical device where software drives or influences the device, you face cybersecurity issues. And in EU-regulated countries, there's the AI Act to consider, though that is a topic for another day and not considered here. Here, we focus ...

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

ISO 13485 Risk Evaluation for Medical Devices explained

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

Cybersecurity in Medical Device Management

MDR Transition Deadlines extended to 2028

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