KAV. I - 22B, 23 & 24, JL. SURYA UTAMA
SURYACIPTA CITY OF INDUSTRY, DESA KUTAMEKAR, KECAMATAN CIAMPEL, KABUPATEN KARAWANG, JAWA BARAT
41363 KABUPATEN KARAWANG
INDONÉSIE
1. Conformity of the devices in accordance with the quality management system under which the devices are manufactured, before a device is released.
2. Technical Documentation and EU declaration of conformity.
3. Post-market surveillance obligations.
4. Reporting obligations.
5. Investigational devices.