Tom Donnelly (Director)

Graduated in Microbiology from Queens University Belfast, and then worked for the healthcare industry in Ireland for thirteen years with Baxter Healthcare and National Medical Care. He has been extensively involved in both US and EU Device and Drug GMP compliance, and his experience encompasses the manufacture of both non-sterile and sterile medical devices (disposable, reusable, implantable and medical equipment), and pharmaceuticals, by terminal and aseptic sterilisation processes.

He has provided auditing, consulting, project management and training services to the healthcare industry since 1991, which has included the preparation of medical device, diagnostic and pharmaceutical manufacturers for FDA and Notified Body inspection, certification of GMP compliance of two medical device manufacturers to the FDA and providing GMP seminars in Europe, USA/Mexico and Asia.

In his career he has directed quality assurance activities in companies such as Baxter Healthcare, National Medical Care, Mallinckrodt Veterinary, and provided consultancy and training services to more than 200 companies including new facility start up activities to ensure compliance with US and EU regulations.

Medicom Associates

Medicom has developed a panel of highly experienced associates who have significant industry experience having worked for both medical device companies and also some regulatory agencies (FDA & Notified Bodies). This panel allows us to deploy the most suitable associates for a particular project.