ISO 13485 is the international standard for quality management systems in the medical device industry. It is a prerequisite for EU MDR compliance and required by virtually every regulatory authority worldwide. NordMDR AB helps manufacturers build, implement and maintain ISO 13485-compliant QMS.
ISO 13485:2016 is the internationally recognised standard for quality management systems specific to medical devices. Under EU MDR, a compliant QMS is required for Notified Body involvement in conformity assessment. Without ISO 13485, Class IIa, IIb and III devices cannot obtain CE marking.
EU MDR Article 10(9) sets out the quality management system requirements that manufacturers must meet. ISO 13485 certification is widely accepted as evidence of compliance with these requirements, though it does not automatically equal full MDR compliance — there are MDR-specific elements that go beyond the standard.
Any manufacturer seeking Notified Body involvement in conformity assessment must demonstrate a compliant QMS. This applies to all Class IIa, IIb and Class III devices. Many importers, distributors and suppliers also require or benefit from ISO 13485 certification.
We assess your current quality management system against the requirements of ISO 13485:2016 and EU MDR Article 10(9), identifying every gap and the specific corrective action needed.
We prepare or review your quality manual, standard operating procedures, work instructions and forms to ensure they meet ISO 13485 requirements and are aligned with EU MDR obligations.
We design compliant processes for design and development, supplier management, complaint handling, CAPA, internal audit and management review — the core processes of any medical device QMS.
We prepare your team for Notified Body QMS audits — including mock audits, process walkthroughs and documentation reviews to identify and address weaknesses before the real audit.
We provide ongoing support for internal audits, management reviews, CAPA management and annual QMS updates to maintain certification and MDR compliance.
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