We prepare the necessary technical documentation for the approval of your surgical instruments in the classes I (including Is, Im, and new for MDR class Ir), IIa, and IIb, according MDR 2017/745 and until May 2020 also MDD 93/42/EEC.
- Device description and specification
- Information to be supplied by the manufacturer
- Design and manufacturing information
- General safety and performance requirements
- Benefit-Risk Analysis and Risk Management
- Product Verification and Validation