MedPass has a long experience working with Ethics Committees and Competent Authorities, assisting our clients, with clinical investigation submissions, contract negotiations and finalization, throughout Europe

MedPass remains at the forefront of the latest regulatory requirements, such as GDPR regulation and applications to clinical investigations in each EU Member State. Our extensive knowledge and experience avoids slowdowns and issues during the regulatory approval and contracting processes that can delay the clinical trial.

Study Documents design and review
Protocol, Investigator Brochure, Patient Informed Consent, Case Report Form for compliance with the requirements of EN ISO 14155
Assist authorities & hospital
Follow up with authorities until final approval. Provide contract templates and assist in budget negotiations with investigators & hospitals
Compilation and submission
EC package to relevant EU Ethic Committees. Compilation and submission of CA package to relevant EU CA’s.
Regulatory Management
MedPass’ Regulatory Affairs Project Manager coordinate regulatory submissions and site agreements using our specialized staff.

An in-depth understanding of the regulations applicable to medical devices, and the ability to work effectively within this complex environment, is vital for successful medical device development. At all stages in the product life cycle, from pre-clinical assessment, clinical trials through CE marking to post market surveillance, MedPass provides the expert regulatory advice you need.