CA/EC Submissions
As a CRO specialized in clinical studies with medical
devices, we can support you with the regulatory and EC/IRB submission and
communication for your medical device clinical trials. Although ISO 14155
prescribes generally the sponsor’s obligations in communicating with Competent
Authorities (CA) and Ethics Committees (EC), there are significant differences
between countries and even within countries between individual ECs, in the way
they work and what they require. National laws and regulations influence the
submission and reporting requirements and timelines. With our experience, we
can assist in efficient communication including; submission, (re-)approval,
maintenance and reporting.