Research and development consultancy services

Tender description

The MHRA and Medical Device Act require medical devices to conform to the regulations. The service will undertake activities to enable that to happen including meeting specific MHRA requirements set out in their exemption letter. • provide medical device regulatory leadership; • develop and implement medical device quality management processes; • undertake a clinical investigation; • clinical evidence processes; • essential requirements; • MDD conformity. The MHRA and Medical Device Act require medical devices to conform to the regulations. The service will undertake activities to enable that to happen including meeting specific MHRA requirements set out in their exemption letter. • provide medical device regulatory leadership; • develop and implement medical device quality management processes; • undertake a clinical investigation; • clinical evidence processes; • essential requirements; • MDD conformity.