Under the EU medical device regulation (MDR, 2017/745), clinical evaluation is a critical activity which can either facilitate or delay the CE marking process.
Italy - UK - USA
Clinical Evaluation
Donawa Lifescience assists small, medium and large multinational medical device companies in meeting clinical evaluation requirements, including:
- Formulation of clinical development strategies
- Development of clinical evaluation plans (CEPs) and clinical evaluation reports (CERs)
- Determination of device equivalence
- Review or development of clinical evaluation SOPs
Maria E. Donawa, M.D., Donawa Lifescience founder and President, with US pharmacy and medical degrees, with a specialization in Clinical and Anatomical Pathology, and over 35 years’ experience in EU and US medical device regulation, manages the clinical evaluation service.
Donawa Lifescience has the knowledge and experience to assist you in the development of effective medical device, IVD and combination product regulatory, clinical study, and quality system strategies, so that important project milestones within planned timelines can be met. Contact us either by e-mail for a confidential discussion about your project, or call Dr. Donawa on +39 06 578 2665.
