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.
- Established in 1993
- Nearly 100 employees
- Production facility of 4000 m2
- 17 million Euro turnover
- EU location
Our clients include
Our services
We offer services, that can be purchased individually or combined into a unique service package.
EU Authorized Representative
- Designated EU Authorised Representative
- EUDAMED Registrations
- Single Registration Number (SRN)
- Competent Authority Liaison
- EU Mailbox and Address
- Vigilance*
- CAPA*
Post-Market Surveillance
- Proactive Real-Time Data Collection and Reporting
- Scientific Literature
- Regulatory Requirement
- Adverse Events
- Authority Publications and Recommendations
- Standards
- Public and Social Media
* Hourly invoiced
Person Responsible Regulatory Compliance PRRC for micro and small enterprises
- Micro: Employees < 10, Turnover and Balance Sheet < 2million€ Small: Employees < 50, Turnover and Balance Sheet < 10million€
- Person Responsible for Regulatory Compliance
- Utilization of PRRC in EUDAMED registrations
- Competent Authority and Notified Body liaison
- PRRC permanently and continuously at disposal
- Includes 4 hours of PRRC work free of charge
Person Responsible Regulatory Compliance PRRC for enterprises
- For companies not in accordance with 2003/361/EC concerning the definition of micro and small enterprises
- Person Responsible for Regulatory Compliance
- Utilization of PRRC in EUDAMED registrations
- Competent Authority and Notified Body liaison
- PRRC part of your organization and payroll
- Includes 4 hours of PRRC work free of charge