RPN services are:
- Advice on the current legislation on Medical Devices
- Regulatory support for the development of new Medical Devices
- Writing and/or revision of technical dossier to obtain CE marking
- Management of the certification procedure and contacts with the notified bodies
- Request of free sales certificates
- Revision of promotional material
- Advice on clinical trials
- Vigilance services
- Management of the national Medical Device database
Liaison with the regulatory authorities
Assist in developing, assembling, reviewing client’s meeting request package and initiate contact with agencies. Attend meetings with agencies.
Facilitation of local concerns via a network of partners in EU countries and USA
Consolidated network of partners in EU countries and a local Agent in the USA allow us to support our clients facing specific local issues.