EU 2017/745 MDR Medical Device Regulation

The preparation of technical documentation under the MDR first begins with the verification and documentation of the design and product realization. In the verification of the design, we prepare your technical documentation in the light of the data obtained with the design of the tests for pre-clinical and performance criteria. If you have processes that need attention and development at this stage, we provide development and evaluation activities to ensure that the product and production become the best. Therefore, for us, technical documentation is not just a writing phase, but a process of upgrading the design to optimal efficiency, where we verify with you all the activities in the product realization phase and review the safety and performance of the medical device.

Our consulting services include:

• Evaluation, classification of products, determination of Basic-UDI,
• Evaluation of product intended use, claims, safety and performance aspects
• EUDAMED and Notified Body Application
• Technical documentation
• Determining safety and performance tests, conducting test and laboratory processes
• Biological evaluation, Conducting BEP & Test & BER processes.
• Risk analysis
• Clinical Evaluation
• Clinical Investigation (with CRO)
• Execution of notified body communication, support until certification is complete,
• Surveillance audit support
• Adaptation of documentation and application to other certification processes such as FDA, MDSAP, UKCA