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.
Donawa Lifescience’s senior management are experienced professionals in their own fields, 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 include all aspects of meeting US FDA and EU CE marking clinical, regulatory and quality requirements.
The company headquarters is in the historic centre of Rome; however, the senior management includes mother-tongue English speakers, and the company’s clinical, quality and regulatory teams all speak and work in English.
Donawa Lifescience holds an EN ISO 13485:2016 certificate from Bureau Veritas Italia, demonstrating its commitment to providing the highest quality services 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, our US sister company can serve as your US Agent, to act as a liaison between your company and the FDA.
If you have clinical, regulatory or quality management system needs, we have the solutions. Contact us to find out how we can help.