Technical documentation
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.
This includes:
- Device description and specification
- Information to be supplied by the manufacturer
- Design and manufacturing information
- Safety and performance requirements
- Benefit-Risk Analysis and Risk Management
- Product Verification and Validation
- Clinical evaluation
- Biological evaluation
- Post market surveillance (PMS)
