- Registration of medical devices according to the MDR. We handle products that meet the MDR requirements from class I-III products
- We handle technical documentation for class I-III products
- We perform validation of various processes according to an agreed process validation plan. Process validations are carried out in connection with injection molding, blow molding, ultrasonic welding, assembly, bag sealing (sterile barrier).
- We are certified according to ISO 9001 and ISO 13485
Examples of process validation we perform:
- Installation Qualification (IQ) This protocol ensures that the system/equipment and its components are installed correctly and to the original manufacturer’s specifications.
- Operational Qualifcation (OQ) This step proceeds after the IQ has been performed. In the OQ, the process window is tested and challenged.
- Performance Qualification (PQ) This phase tests the ability of the process to perform over long periods of time within tolerance deemed acceptable.
- Validation Report (VR)
Calibration of major equipment, accessory equipment, and/or utilities should be performed in this step as well.
PQ is performed on the manufacturing process overall. Individual components of the system are not tested individually.
Written consent from the customer/Quality Department releases products for delivery.
