Alex Mitchell

Fearsome delivers comprehensive design & development services to clients in the medical devices industry, with core competencies in technology development, design engineering, product design, human factors, usability engineering, design transfer, design quality assurance, regulatory compliance, and project management. We can tackle a whole project in a turnkey fashion or feed into a wider programme where there is a particular need. We are ISO 13485 certified, with regulatory experience across FDA 21 CFR Part 820 and EMA MDR/IVDR frameworks. Specific areas of expertise include drug delivery and combination products, ophthalmic devices for diagnosis and treatment, surgical instrumentation, wearable and implantable devices.