MEDTECH360 supports you in product development according to EN IEC 60601-1 and its accompanying standards.
- Takeover of sub-projects
- Requirements/ Specifications Engineering
- Integration of risk management
- Validation planning and execution
- Verification planning and implementation
The technical documentation (also product file) is used to prove conformity with European directives and regulations.
It is currently gaining great importance for the successful approval of your products, especially due to the changeover to the MDR (Medical Device Regulation).
MEDTECH360 will be happy to support you in setting up or analyzing the technical documentation of your products. Please contact us!