ISO 13485:2016 specifies quality management requirements for organisations involved in the life cycle of medical devices. We help design QMS processes for design and development, supplier controls, production, complaint handling and post-market surveillance.
Who it is for
- Medical device and diagnostics manufacturers
- Contract manufacturers and component suppliers
- Software as a medical device developers
What you gain
- Supports regulatory submissions in many markets
- Design controls and traceability built in
- Risk management aligned with ISO 14971
Your path to certification
Gap assessment
We compare what you do today with every requirement and control, then give you a prioritised gap report and a realistic timeline.
Design and documentation
Scope, policies, procedures, risk methodology and records, written to fit how your teams actually work, not a template binder.
Implementation and training
We help owners put controls in place, train the people who run them and start collecting evidence.
Internal audit and management review
An independent internal audit and a structured management review prove the system works before the certification body looks at it.
Certification audit support
We prepare you for Stage 1 and Stage 2 with your chosen accredited certification body and help close any findings quickly.
Surveillance and continual improvement
Optional managed support keeps evidence current through annual surveillance audits and the three-year recertification.