[Exhibition Overview] Electrical Safety Testing ・Support for market entry into the US (e.g. FDA ASCA Programme)
・Support for market entry into Europe (MDR/IVDR compliance, usability, software evaluation, etc.) ・Support for market entry into China (compliance with China’s NMPA, etc.) ・Electrical safety testing under the CB Scheme, and issuance of CB reports and CB certificates ・Technical advisery and preliminary structural evaluation
Medical Device Regulatory Support
・Certification and Audit Support: Former auditors from a registered certification body with over 15 years’ experience provide advisory services regarding manufacturing and marketing authorisation for medical devices.
・Regulatory Compliance Advisory: Consultation on regulatory requirements (safety measures, manufacturing and marketing authorisation, etc.) during medical device development
Cybersecurity ・Vulnerability assessment / Penetration testing / Hardware penetration testing / Security review and threat risk assessment ・IEC 81001-5-1 ・IEC TR 60601-4-5 Electromagnetic Compatibility (EMC) Testing ・EMC compliance testing and application support for overseas markets (including North America (FCC), Europe (CE) and Taiwan (BSMI)), as well as EMC standards for medical devices (IEC, JIS T, etc.) ・EMC testing under the CB Scheme, and issuance of CB Reports and CB Certificates ・Wireless coexistence testing (ANSI C63.27, etc.)