Regulatory Affairs

Development of a medical accessory requires integration of Regulatory Affairs in every step of the process. To reduce time to market, experience is critical. We provide full-service Regulatory Affairs and Quality Assurance expertise to our customers. Our Regulatory Affairs specialists have the expertise to ensure that proper regulatory management is part of your project from the beginning. 

Our result-driven, experienced team delivers support in all areas of Regulatory Affairs and Quality Assurance. We have expertise in many international standards and regulations.  As a medical device company we are ISO 13485:2003 certified and work according the MMD 93/42/ECC directive and the FDA Quality Systems Regulation 21 CFR.820. 

We can assist with your FDA 510(k) submissions for the US and with CE registration of your device in Europe and/or act as your Authorized Representative in line with the regulations of the MDD/93/42/ECC directive.

We want to answer simple legal questions and complex RA issues in an international and dynamic environment.