RAPIvD has the knowledge to work to the new IVDR and ISO 13485:2016 requirements. We successfully helped two facilities obtain their ISO 13485:2016 certification.
•RAPIvD can support Clients in getting their ISO 13485:2012 to the ISO 13485:2016 Standard
•RAPIvD can support Clients in setting up their own manufacturing facility and develop their Quality system to the ISO 13485:2016 Standard
ISO 62304 Software Life Cycle
•RAPIvD provides guidance in developing your software to the ISO 62304 Standard
•RAPIvD can develop bespoke monitor software and APPS to the ISO 62304 Standard