deGRANDSON Global Blog | ISO 13485 (2)

News and Commentary on ISO Management System Standards

22 Apr 2025

IVDR Transition Deadline extended up to 2027

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.

11 Feb 2025

Essential Documentation for ISO 13485 Certification

ISO 13485

QMSR & ISO 13485: On 02-Feb-26, the FDA Final Rule 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. There are 139 (sic) instances in ISO 13485:2016 Standard where documentation is mentioned. In developing your documentation, ...

21 Dec 2024

ISO 13485 Certification in the Medical Device Supply Chain

ISO 13485

QMSR & ISO 13485: On 02-Feb-26, the FDA Final Rule 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. Suppliers to Medical Device Manufacturers should also have ISO 13485 Certification The medical device industry operates ...

24 Oct 2024

Medical Devices: Managing Residual Risk and Risk Tolerance

ISO 13485

QMSR & ISO 13485: On 02-Feb-26, the FDA Final Rule 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. Managing residual risk and understanding risk tolerance are crucial aspects of ISO 13485 compliance. ISO 13485:2016 is an ...

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 ...