Support Services

We secure and support the clinical Safety and efficacy of artificial intelligence medical software,
medical robot, and medical devices.

HOMEHOME화살표Support service화살표Support for certification / approval process

Support for certification / approval process

In CARE, we provide support for the
government relation service of the regulatory agency,
as well as documents and guidance required in each step
of the certification / approval process.
Step 1

Service of confirming the availability, class, classification
and status of the medical device through the review of products to certification / approval

Step 2

Subject of technical document review or performance and effectiveness evaluation

Step 3

Safety test report, performance test report, technical document, clinical study data, and (clinical) GMP consulting / connection

Step 4

Supplement and management of documents until completion after the certification / approval submission

인·허가 기술지원