Donawa Lifescience is a leading international CRO and quality/regulatory consultancy for medical devices, in vitro diagnostics (IVDs) and combination products. The company, headquartered in Rome, Italy and its subsidiary, Donawa Lifescience, Inc., operating in Cambridge, Massachusetts, USA, provides a seamless, integrated service for medical device companies seeking a single source for advancing their products from feasibility to commercialization.
Maria E. Donawa, M.D., President and company founder, a US citizen, 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 Device Directives, and EN 46001, the forerunner of ISO 13485.
Donawa Lifescience senior management are experienced professionals with extensive government and industry experience, who work as a cohesive unit to provide tailored support to medical device and IVD manufacturers, from start-ups to multinationals. The services offered address all aspects of meeting US FDA and EU CE marking clinical, regulatory and quality management system (QMS) requirements. Donawa Lifescience works primarily in English, with most staff members being bilingual.
Clinical research was added to the service portfolio in the late nineties, with the company becoming a full service CRO for medical devices, IVDs, and drug/device combination products, while maintaining the company’s expertise in device quality systems and regulatory affairs.
The Donawa Lifescience QMS is certified to EN ISO 13485:2016 by Bureau Veritas Italia, demonstrating its commitment to quality in its operations and the services provided to its clients.
If your company is located outside Europe, Donawa Lifescience can serve as your European Authorized Representative, to act as a liaison between your company and national regulatory authorities. If your company is located outside the United States, Donawa Lifescience, Inc., can serve as your US Agent, to act as a liaison between your company and FDA. We also have a sister company located in the UK that offers UK Responsible Person services for compliance with the new post-Brexit regulations being overseen by the MHRA.
If you have clinical, regulatory or QMS needs, we have the solutions. Contact us to find out how we can help.