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How to implement quality management for medical devices
The steps toward quality management for medical devices
The experts at TÜV Rheinland will accompany you along the route to ISO 13485 certification, providing their expertise and tactful advice along the way. This involves six steps:
1. Preliminary audit (optional)
The auditors conduct a preliminary audit.
They determine whether any requirements associated with this standard have already been implemented in your company and, if so, which ones.
2. Document review
The audit team determines the extent to which the documentation for your quality management system already meets the requirements of ISO 13485.
3. Certification audit
You demonstrate the practical application of your quality management system and our auditors test its effectiveness.
4. Issue of certificate
Once all criteria have been met, your company will receive its certificate. It certifies the integrity of your quality management system and its compliance with ISO 13485.
5. Surveillance audits
Our annual surveillance audits help you continually optimize your processes.
6. Recertification audit
The recertification audit takes place three years after the original audit and enables you to implement continuous improvement processes. This demonstrates to your customers that you have a long-term commitment to the safety of your products.
