deGRANDSON Global Blog | ISO 13485 (2)

News and Commentary on ISO Management System Standards

21 Sep 2023

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

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

Cyber Security in Medical Device Management

ISO 13485, ISO 27001

Did you know that cybersecurity is addressed under ISO 13485:2016 Clause 7.3 requirements? The Royal Academy of Engineering (RAE UK) report ‘Cyber Safety and Resilience’ (March 2018) suggests that the healthcare sector can learn from other industries when it comes to guarding against ransomware attacks, data breaches and hacking of connected health devices. That was just the beginning. Since ...

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

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

Cyber Security in Medical Device Management

MDR Transition Deadlines extended to 2028

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