Scientific Affairs
We conduct in-depth clinical evaluations of commercial medical devices, applying industry and clinical expertise.
Preclinical Research
- Design and planning of scientific experiments
- Design of animal studies
Clinical Evaluation & Medical Writing
- Clinical evaluation of medical devices according to MDD / MDR
- Scientific literature research as well as evaluation of literature and presentation of current scientific state of the art on clinical issues (for pre- and post-marketing)
- Preparation and revision of product-specific documents (as for example Instructions for Use) with a medical focus
- Review of scientific texts and documents
- Identification, evaluation and analysis of scientific data
- Preparation and revision of annual reports, e.g. SSCP and PSUR
Medical Device Vigilance
- Advice / support on medical device vigilance
- Medical assessment of risks and advice on risk minimization
- Medical evaluation of incidents, Adverse Events (AE) and Serious Adverse Events (SAE)
Consulting & Training
- Medical lectures on e.g. medical devices, their indications, surgical techniques, possible complications and perioperative risk management
- Interface consulting between product development and clinic based on the clinical processes and the available data
- Design and preparation of scientific presentation as well as submissions for third-party donors
- Advice on the design of Post-Market Surveillance (PMS) measures including Post-Market Clinical Follow-up (PMCF)
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