The Medical Devices team at TFS has experience in managing device investigations in compliance with the applicable directives and harmonised standards.
We can provide a wide range of medical and scientific services required to support all stages of medical device development.
TFS is able to provide global trial support as well as specific advice on compliance with regional and national requirements.
Our services include:
Medical device clinical evaluations and clinical investigations / performance evaluations
- Study design and protocol development
- Management and monitoring of clinical investigation
- Post market Clinical Investigations
- Data management and biostatistics
- Audits of all types of clinical evaluations
- EU clinical evaluation reports (CER) and literature reviews
- Medical device classification
- CE Mark consulting
- Selection of and liaison with Notified Bodies
- Submission of requests for authorisations to competent authority / regulatory authority to
- Submissions for ethical approvals
- Technical file or design dossier preparation for obtaining European CE marking
- Medical device vigilance reporting in Europe
- Introduction to medical devices (overview of regulations, classification, routes to CE marking)
- ISO 14155 GCP for clinical investigations