Our team specialized in medical devices supports you in the regulatory and clinical development of your device as well as in its clinical evaluation, in accordance with European Regulation 2017/745.
| The class and status of your device | ||
| The necessary steps to obtain CE-marking | ||
| The clinical use of your device (intended use, indication, population and users) | ||
| The clinical claims of your device (performance, benefit and safety) | ||
| The regulatory and clinical strategy to implement | ||
| Definition of the clinical evaluation strategy (own clinical data, equivalence, Well-Established Technology or Article 61(10)) | ||
| Writing of the Clinical Evaluation Plan (CEP) | ||
| Conduct of the evaluation and witing of the Clinical Evaluation Report (CER) | ||
| Definition of the post-market clinical follow-up strategy | ||
| Writing of the Post-Market Clinical Follow-up Plan (PMCFP) | ||
| +70 | Clinical evaluation conducted by experts | |
| On medical devices of all 3 classes : | I, IIa, IIb, III | |
| Including implants, software and devices without medical intended prupose | ||
| 4 | Using all type of strategies: own clinical data, equivalence, WET and article 61 (10) | |
RCTs organized a series of free webinars (in French) dedicated to the clinical evaluation of medical devices. Find out more about these webinars here.