Device Clinical Trial Consulting

Dt&SanoMedics considers it a great privilege to change people's lives into better lives together with clients.

ISO 14155

For the strengthening device regulation market

Device clinical trial consulting for the strengthening device regulation market with ISO 14155.

We are the first CRO in Korea to be certified ISO 14155 and provide the latest services from medical device development to licensed technical documents for enhancing acceptance under the enforced MDR (Medical Device Regulation).

TÜV SÜD certificate No. Q4B 110244 0001 Rev. 00 issued to Dt&SanoMedics Co., Ltd. for designing, planning and conducting clinical investigations with medical devices, applied standard ISO 14155:2020, dated 2021-03-12, valid until 2024-03-11.
Certificate

ISO 14155:2020

Certification Body of TÜV SÜD Product Service GmbH · No. Q4B 110244 0001 Rev. 00