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 mission is to provide high quality services with a personal touch. We cooperate closely with our customers, helping them to grow together with a reliable partner. We understand our customers’ needs and assist them to be one step ahead on the fast-moving market.  

ISO Certification
  • Established in 1993 
  • Nearly 100 employees 
  • Production facility of 4000 m2 
  • 17 million Euro turnover 
  • EU location 

Our clients include

MDBS Clients

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

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