The post-market surveillance becomes under the MDR an integral part of the quality management. All data on quality, performance and safety of a product is collected here throughout its entire life cycle. Within the PMS process, the data is regularly evaluated, analysed, appraised and, if necessary initiate measures. 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. Due to its complexity, it represents a special challenge for medical device manufacturers.
Depending on the product, its application and risk, numerous data are obtained, collected, evaluated and appraised in this supreme discipline. In order not to lose the overview and obligatory time periods, this needs a good organisation. Besides a post-market surveillance plan, obligatory report periods depending on the medical device class are binding. For implants and class III medical devices, a safety report is part of the conformity assessment. This safety report and the Notified Body’s assessment report will in future be available to competent authorities via an electronic system. In addition, a summary report on safety and clinical performance must be made available to the public for implants and class III medical devices.
Your challenge is our mission. We support you individually and according to your needs:
- Preparation of your individual post-market surveillance plan of your product.
- Performing and reporting on post-market surveillance up to the preparation of the safety report.
- Summary report on safety and clinical performance.
Documentation in English language, optionally in German language.