In Vitro Diagnostic Regulatory Affairs, Quality Assurance and Compliance
Providing consulting services
In Vitro Diagnostic Regulatory Affairs, Quality Assurance and Compliance
Providing consulting services
Our Services
IVD Regulatory Affairs
EU IVDR 2017/746, UK MDR 2002 and Global IVD medical device regulatory advice
Quality Assurance - ISO 13485 implementation
Implementation, and maintenance of effective ISO 13485 Quality Management System
Wider product and business compliance considerations
Considerations beyond the sectorial regulation that impact IVDs.Including Chemicals and Environmental and Sustainability regulations.GHS/CLP, REACH, RoHS, WEEE etc. as well as the upcoming impact of regulatory changes under the EU Green Deal and UK post BREXIT divergence.