deGRANDSON Global Blog | ISO 13485 (2)

News and Commentary on ISO Management System Standards

21 Dec 2024

ISO 13485 Certification in the Medical Device Supply Chain

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 ...

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 ...