Clinical Evaluation / Performance Evaluation
You have developed a new medical device or an IVD? During the R&D work you have become a specialist for this indication and its technical solutions but what about the Clinical Evaluation Report - or a Performance Evaluation Report in the wording for IVDs? With the experts of our clinical team we have profound experienced experts to support you with the preparation or update of Clinical Evaluation Reports.
- We are not only aware of all relevant standards, but are also able to develop clinical wording which is commercially optimal and convincing by using resources such as:
- MEDDEV 2.7.1, rev.4
- MEDDEV2.14/2 rev.1
- Systematic clinical literature search and reporting
We know what the Notified Body requires both in terms of content and format.
Clinical Investigations / Post-Market Clinical Follow-up Studies
What about clinical investigations? The experts of our clinical team can support you with the generation of clinical data for your product that comply with the new regulation. Our main activities:
- analyse the publicly available / own clinical data and determine their acceptability under the MDR, assist with the planning of your clinical investigations / PMCF studies.
- assist with creating your PMCF plan and necessary documentation
- clearly define the objective of your clinical investigation / PMCF study
- ensure the acceptability of the proposed study plan by your Notified Body upfront
- prepare and submit the required documentation to Ethic committees and competent authorities (if applicable)
- ensure compliance of the clinical investigation according to ISO 14155 requirements
Biocompatibility / Biological Safety / Preclinical Evaluation
In addition to clinical evidence for performance and safety of a medical device, evaluation of the biocompatibility of a product (e.g. according to EN ISO 10993-X) is one of the critical milestones on the path to CE certification. We are glad to support you in gathering the necessary evidence, e.g. by:
- Identification of required evidence / tests (e.g. cytotoxicity, sensitization, irritation, etc.)
- Literature research on raw materials
- Identification and coordination of test laboratories
- Writing of the preclinical evaluation report according EN ISO 10993-X