Donawa Lifescience is a leading international clinical research, regulatory and quality consultancy, based in Rome, Italy, providing a seamless, integrated service for medical device companies who are seeking a single source for progressing their products from feasibility to commercialisation. Maria E. Donawa, M.D., began her consultancy in Rome shortly after serving six years with the US FDA’s Center for Devices and Radiological Health (CDRH), offering quality system and regulatory assistance to companies learning to cope with the US Medical Device Amendments, European Medical Devices Directive, and EN 46001, the forerunner of ISO 13485. Clinical research was added to the service portfolio in the late nineties with the company becoming a full service Clinical Research Organisation (CRO) for medical devices, in vitro diagnostics (IVDs), and drug/device combination products, while maintaining the company’s expertise in device quality systems and regulatory affairs.
Phone: +39, 06, 578, 2665
Fax: +39, 06, 574, 3786
E-mail: contact@donawa.com
Web: https://www.donawa.com
Add：Piazza Albania, 10, 00153 Rome, Italy
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