Standardized production is an important aspect of the production process in medical technology, as medical devices and products must be produced and marketed according to strict laws and regulations. As part of the Medical Device Directive and the Medical Devices Act, there are severall standards and regulations that companies must respect if they want to successfully place their product on the German and European market. This not only applies to the distributors, but also to suppliers and OEM’s.
We help you with all steps around the compliance and introduction of the different standards.
- Implementation of DIN EN ISO 13485
- Gap-analysis of DIN EN ISO 13485:2012 vs. DIN EN ISO 13485:2016
- Gap-analysis of DIN EN ISO 9001:2008 vs. DIN EN ISO 9001:2015
- Gap-analysis of ISO/TS 16949 vs. DIN EN ISO 13485:2016
- Preparation of work instructions and forms
- Intern audits & qualifcation suppliers
- Preparation for audits by the notfied body
- Documentation and data backup
- Necessary training of your personnel
senetics already successfully accompanied over 25 companies on their way to a certified QM-system. We are happy to be available for a personal first meeting!