In Vitro Diagnostics EU/US Quality and Regulatory Services
 
 
Your partner from successful product launch to reaching your business objectives and beyond
 
 
US and European Device Regulatory
 
For over 20 years, a recognized resource for reliable and accurate US and European medical technologyregulatory expertise, including IVD instruments and reagents. Gemar also provides highly respected European Authorized Representative services.
 
 
Quality Systems
 
Gemar is a recognized leader in US and European quality system development, implementation, assessment and compliance. Equally proficient with ISO 13485, 21 CFR 820 and PAL 169 quality systems.
 
 
Software Compliance
 
Compliance of medical device software with US and European regulatory requirements needs very specific expertise, which Gemar has available to assist companies, from early development to market clearance.
 
 
Environmental Services
 
A new service for device companies, provided by our experienced Environmental Affairs Associate, helping companies meet the growing list of European environmental directives and standards.
 
Performance Evaluation Studies in Europe, US and Canada
 
 
We are a full-service CRO specializing in medical devices, IVDs and combination products, managing and monitoring studies that are valid for the US and elsewhere. Feel free to contact us and see how we can assist you.