Clinical Affairs, Regulatory Affairs, Coding/Reimbursement

Joint Solutions has experienced consultant with expertise in the following areas:

Services

Europe

• ISISO 9002, ISO 9001, ISO 13485
• CE file completion for medical devices Class I, II a, II b, III
• Setting up Regulatory Affairs Departments
• Reimbursement TIPS (France) and liaison with the Afssaps (equivalent of the FDA in France)
• Clinical Affairs: protocol set-up, study monitoring, report production, from one centre to multicentre studies
• Conduct Quality Audit for small companies
• Vigilance Officer and authorized representatives for the CEE

USA

• Implementation of a procedure in relation to FDA and QA systems
• Manage FDA audit for class I, II, III devices approved in the U.S.
• Set-up files for a 510(k)

Far-East

• Korea, Japan, Australia, China
• Set-up of registration files
• Manage the file through registration process

Europe, Far-East & USA

• Establish 3rd party partner for regulatory approval and product introduction
• Set-up of distribution network, Negotiation, Distribution Agreement,
  Training program
• Set-up of clinical studies for marketing purposes