Documentation for clinical compliance testing
In addition to the medical quality of the clinical evaluation, its documentation and traceability must also be ensured in the context of complex reports and plans. The reporting system includes the results of the clinical evaluation if applicable. including clinical trial documents such as study protocol, investigator's brochure, patient information and informed consent, as well as additional reports and plans such as the Clinical Development Plan and the Summary of Safety and Clinical Performance (SSCP). MEDDEV 2.7 / 1 rev. 4 also sets requirements. The clinical evaluation can also be tested in conjunction with risk management.
Documentation of clinical post-market surveillance
There are also the documents of the clinical PMS. This documentation includes major innovations by MDR
additional reports and plans such as the Post Market Surveillance Plan / Report (PMS), the Post Market Clinical Follow-up Report (PMCF), the Periodic Safety Update Report (PSUR) and the Summary of Safety and Clinical Performance (SSCP).
For defined product groups, manufacturers must submit the safety / clinical evaluation / performance summary reports on the safety and performance of their products annually. In particular, this applies to Class III medical devices and implantable devices that have higher clinical requirements for clinical PMS in 2017 EU MDR.
Clinical Writing and Documentation.
Prof. Zenner & his partners in the specialist network can support the preparation of the necessary documents by means of clinical writing.
The methods of Clinical Writing can be found here...