As a medical device manufacturer, you are very aware of MEDDEV 2.7/1 rev. 4. from 2016. Following this document when planning and executing your Clinical Evaluations is crucial in helping you meet the MDR requirements that will be implemented May 26th 2021.

The most critical requirements of MEDDEV include: Clinical Evaluations must be linked to safety, performance and risk-benefit endpoints; the frequency of updates, qualification of Clinical Evaluation Report author(s), etc. Furthermore, there are requirements concerning the scientific and statistical validity of data, the specifications when the Clinical Investigation is to be performed, and the strict requirements for demonstrating the equivalence.

We are here to help.

Our team has experience in searching literature resources, biostatistics, medical writing of study protocols and/or study reports, appraising scientific and methodological quality of clinical data, and performing clinical investigations according to ISO 14155. With this experience our team delivers a successful Clinical Evaluations. Our team has experience in searching literature resources, biostatistics, medical writing of study protocols and/or study reports, appraising scientific and methodological quality of clinical data, and performing clinical investigations according to ISO 14155. With this experience our team delivers a successful Clinical Evaluations.

We suggest to start with our gap analysis of your clinical data:

Given that the gap analysis doesn’t show any missing clinical data we assist you with compilation of a Clinical Evaluation Report. Our Reports not only meet all current requirements, like the MEDDEV and the MDR, but also MDCG and IMDRF guidelines.

If you are interested in more details, please feel free to contact me at jpaseka@gcp-service.com or +420774735206. Please follow us on as we continuously give you helpful hints for successful Clinical Investigations. There are many ways of cost-effective data collection, and the most important is to start as soon as possible.

Looking forward to hearing from you soon!

Jiri Paseka