The clinical evaluation is a key document in CE certification. Its importance will increase further under the MDR. However, it contains challenges that can endanger the CE certification.
On 26.05.2020 ends the transition period of the Medical Devices Regulation. Prepare early to secure market access for your products and benefit also from a competitive advantage.
Post-market Surveillance (PMS)
The post-market surveillance becomes under the MDR an integral part of the quality management. At its heart will be a key position in the future, which will be decisive for successful product certification and the maintenance of the certification.
Post-market clinical follow-up (PMCF)
Post-market clinical follow-up is an ongoing process to assess the safety and performance of a medical device throughout its entire life cycle. As an integrated part of the clinical evaluation, it will be essential in the future.
Only biocompatibility studies to assess the biological safety of medical devices are no longer sufficient. In addition to the risk-based approach, it is now also necessary to consider biocompatibility and possible toxicological effects throughout their entire life cycle.
Risk management remains a key document in technical documentation. Benefit from the early identification of risks and secure your company's success.
Preparation and Maintenance Technical Documentation
The technical documentation of medical devices will also change under the MDR. Take the opportunity to critically review and carefully revise the file at an early stage.
CE Certification of medical devices
We support you in the preparation or revision of key documents for your CE certification. On desire, we make also the communication to your Notified Body. Choose which modules you need.