Medical consulting - Import export

Worldmed Assistance Nepal manages medical assistance services on behalf of our international partners, insurance companies, medical provider, and acts as their local correspondent in the country.

Medical Device Services / Medical Device Laboratory Testing INVITRO-CONNECT GmbH offers you: - General regulatory advice for medical devices - All regulatory examinations and tests under GLP - Project management and study monitoring - Medical Device Regulatory Service - Product testing for contained SVHC substances INVITRO-CONNECT offers you a complete service for the approval of medical devices according (EU) 2017/745 (Medical Device Regulation - MDR) / ISO 10993. From the development of an ideal test strategy to laboratory and project coordination, study monitoring, toxicological expertise and GLP inspections in the cooperation laboratories. We deliver the finalized test reports including the registration dossier - digitally and on paper, worldwide. Benefit from our diverse know-how, our experienced cooperation partners and an international, very well-organized network. Questions? -> contact@invitro-connect.com

The new European Commission’s guidance on persons responsible for regulatory compliance (PRRC) explains that manufacturers, Authorized Representatives and micro and small manufacturers must designate at least one staff member responsible for ensuring compliance to the MDR and/or IVDR as appropriate according to Article 15 of the Regulation. PRRC qualifications are specific for each of these three operators. This does not mean that you have to hire PRRC as employee rather you can avail our PRRC service to overcome the regualtory needs of your company and medical devices – with a consultant managing the system on a few days per month basis. We would be more than happy to discuss this option with you, helping you to find a consultant with the necessary qualifications to perform this service effectively. If you would like to know more about this service, then please contact us.