Medical Device Business Solutions Logo

Providing business solutions to medical device 
manufacturers worldwide. 

Meeting the regulatory requirements of new markets is a common challenge for medical device manufacturers. Medical Device Business Solutions provides regulatory compliance services that combine our years of experience in the medical device industry with the use of latest technology. We offer simple service packages, designed according to the actual needs of medical device manufacturers and startups, both inside and outside of the European Union.  

Our services

We offer services, that can be purchased individually or combined into a unique service package.

EU Authorized Representative

€ 199 per Month
  • Designated EU Authorised Representative
  • EUDAMED Registrations
  • Single Registration Number (SRN)
  • Competent Authority Liaison
  • EU Mailbox and Address
  • Vigilance*
  • CAPA*

Post-Market Surveillance

€ 399 per Month
  • Proactive Real-Time Data Collection and Reporting
  • Scientific Literature
  • Regulatory Requirement
  • Adverse Events
  • Authority Publications and Recommendations
  • Standards
  • Public and Social Media

* Hourly invoiced

Get started

Questions?

We are more than happy to consult you about your company’s specific regulatory compliance needs.

Please fill in the form above and we will get back to you as soon as we can.