Under EU medical device requirements, clinical evaluation is a critical activity which can either facilitate or delay the CE marking process. It will continue to be critically important under the European Medical Devices Regulation (MDR; EU 2017/745), which becomes mandatory on 26 May 2020.
Donawa Lifescience Consulting (DLC) assists small, medium and large multinational medical device companies in meeting clinical evaluation requirements, including:
- Development of a clinical data strategy
- Determination of device equivalence
- Review or development of clinical evaluation SOPs, and
- Development of clinical evaluation reports (CERs).
Dr. Maria E. Donawa, DLC founder, with US pharmacy and medical degrees, with a specialization in Clinical and Anatomical Pathology, and over 30 years’ experience in EU and US medical device regulation, manages the DLC clinical evaluation service.
DLC 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. Maria Donawa, President, on +39 06 578 2665.