Medical Devices
The best partner - right from the start
In the past, approval and market introduction of medical devices used to be less time-consuming, but nowadays the requirements have increased considerably. For each medical device, regardless of the risk class, a clinical evaluation must be conducted and documented. In this context, clinical performance data and clinical safety data relevant to the intended purpose of the device in question have to be appraised and analysed.
The clinical evaluation is based on clinical data collected from scientific literature and/or clinical investigations/trials.
We would be glad to support you with data collection and preparation of your clinical evaluation:
Systematic literature search
- Medical and scientific databases
- Technical publications of relevant committees and professional medical associations
- Information from competent authorities
- Other literature, such as dissertations, diploma theses, internet
- Original data from published clinical trials
- Data generated and held by the manufacturer
Clinical trials of medical devices: All-round support from planning to completion and evaluation
Quality assurance
Medical writing
Data collection – (e)CRF/databases
- Vigilance
- Post-Market Clinical Follow-up
- Literature search
We would also be pleased to directly support you on-site in your company!