ISO 13485 sets out quality management system requirements for organisations involved in any stage of the medical device life cycle, from design and production to storage, distribution, installation and servicing. It is built on ISO 9001 but adds regulatory-driven requirements around risk management, design controls, traceability and record retention.
What ISO 13485 delivers for your organisation.
The core requirements your organisation will need to meet.
Quality management system documentation and medical device file
Risk management applied across product realisation
Design and development planning, verification and validation
Control of production, sterile processes and cleanliness where applicable
Traceability, identification and record retention periods
Complaint handling, vigilance reporting and post-market feedback
Our structured approach from initial assessment through to completion.
We assess your current system against ISO 13485 and the regulatory requirements applicable to your device class.
We build the quality manual, medical device file, design history structure and supporting procedures.
We train your team on design controls, risk management and traceability, then run an internal audit.
We prepare you for Stage 1 and Stage 2 and support closure of any findings.
Our expertise spans across diverse sectors, delivering tailored certification solutions.
Common questions answered by our consultants.
Others we support in Quality Management.
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