Certifications
To fulfill the inherent responsibility of a medical device company, i-SENS, Inc. holds a total of seven ISO international certifications and complies with global standards across seven areas: quality, environment, safety and health, information security, business continuity, anti-bribery, and compliance.
1. Integrated Status of ISO Certifications
No. | Certification | Description | Validity Period | Area |
1 | ISO 13485 | Medical Device Quality Management System | April 1, 2026 – March 31, 2029 | Quality |
2 | ISO 14001 | Environmental Management System | October 10, 2025 – August 23, 2028 | Environment |
3 | ISO 22301 | Business Continuity Management System | August 24, 2024 – August 23, 2027 | Risk |
4 | ISO 27001 | Information Security Management System | January 20, 2025 – January 19, 2028 | Information Security |
5 | ISO 45001 | Occupational Health and Safety Management System | August 24, 2025 – August 23, 2028 | Occupational Health and Safety |
6 | ISO 37001 | Anti-Bribery Management System | April 4, 2025 – April 3, 2028 | Ethics |
7 | ISO 37301 | Compliance Management System | April 4, 2025 – April 3, 2028 | Ethics |
2. ISO Certifications by Area
Area | Applicable ISO Certification | Business Significance |
Quality | ISO 13485 | Operation of a globally integrated QMS for medical devices — foundation for FDA, CE, and MDSAP licensing |
Environment | ISO 14001 | Environmental management of GHG, waste, and resource circulation — foundation for response to EU CSRD and CBAM |
Safety and Health | ISO 45001 | Response to the Serious Accidents Punishment Act; safety management at Songdo and Wonju sites |
Information Security | ISO 27001 | Security of patient data and CGM algorithm training data — response to EU GDPR and HIPAA |
Business Continuity (BCM) | ISO 22301 | Prevention and recovery from business interruption incidents — securing operational continuity across four sites |
Ethics and Compliance | ISO 37001 + ISO 37301 | Integrated anti-bribery and compliance management — alignment with UNGC Ten Principles and integrity management |
3. Status of Certification Renewals and Management
With the new acquisition of ISO 37001 and ISO 37301 in April 2025, the certification scope has been expanded to the areas of anti-bribery and compliance. With the renewal of ISO 13485 in April 2026, the Medical Device Quality Management System certification will be maintained through 2029. The renewal procedure for ISO 45001, which is scheduled to expire in August 2025, is currently underway just before expiration.
Year | Renewal · New Certification | Status |
2022 | ISO 14001 renewal (effective July 14, 2022; expires August 23, 2028); ISO 45001 renewal (effective August 24, 2025) | Completed |
2024 | ISO 22301 renewal (effective August 24, 2024; expires August 23, 2027) | Completed |
2025 | ISO 27001 renewal (effective January 20, 2025); ISO 37001 and 37301 new certifications (effective April 4, 2025) | Completed |
2026 | | ISO 13485 renewal (effective April 1, 2026; expires March 31, 2029) | Completed |
4. ISO Certificate PDF Attachments
No. | Attached File Name | Notes |
1 | ISO 13485 | Quality Management System (Medical devices — Quality management systems — Requirements for regulatory purposes) |
2 | ISO 14001 | Environmental Management System (Environmental management systems) |
3 | ISO 22301 | Business Continuity Management System (Business Continuity Management Systems — Requirements) |
4 | ISO 27001 | Information Security Management System (ISMS, Information Security Management Systems) |
5 | ISO 45001 | Occupational Health and Safety Management System (Occupational Health and Safety Management Systems — Requirements) |
6 | ISO 37001 | Anti-Bribery Management System (Anti-Bribery Management Systems — Requirements) |
7 | ISO 37301 | Compliance Management System (Compliance Management Systems — Requirements with guidance for use) |
5. Additional Licensing (Global Medical Device Licensing)
In addition to ISO certifications, i-SENS, Inc. satisfies all global medical device licensing regimes.
Licensing | Scope | Role |
FDA 510(k) | U.S. medical device licensing | Foundation for U.S. market entry for BGM and CGM (first BGM approval in 2008) |
CE Marking + EU MDR | European medical device certification | European entry for BGM and CGM (CareSens Air obtained EU CE in 2024) |
MDSAP | Integrated audit for Australia, Brazil, Canada, Japan, and the United States | Single QMS satisfying all five countries simultaneously |
MFDS GMP | Korean Good Manufacturing Practice for medical devices | Foundation for the No. 1 domestic BGM and POCT businesses |
NMPA | China medical device licensing | China market entry for i-SENS Jiangsu |
PMDA QMS | Japan conformity assessment | Response to the Japanese market |
CDSCO | India medical device licensing | Response to the market for i-SENS BIOSENSORS INDIA |
6. Global Standards Mapping (Certification-Based)
The seven ISO certifications and seven global medical device licenses on this page are mapped 1:1 to the following global-standard disclosures.
Certification · Licensing | GRI | ESRS | SASB HC-MS | Regulatory Alignment |
ISO 13485 (Medical Device QMS) | 3-3, 416-1 | S4-5 | HC-MS-250a.1 | Foundation for EU MDR, FDA QSR, and MDSAP 5-country |
ISO 14001 (Environment) | 302, 303, 305, 306 | E1, E2, E3, E5 | — | Foundation for EU CSRD, CBAM, and EU PPWR response |
ISO 45001 (Occupational Health and Safety) | 403-1 ~ 403-10 | S1-14 | — | Response to the Serious Accidents Punishment Act |
ISO 27001 (Information Security) | 418-1 | S4-3 (Consumer Privacy) | HC-MS-230a.1 | EU GDPR, HIPAA, Korea Personal Information Protection Act |
ISO 22301 (BCM) | 2-25 (Remediation) | ESRS 2 IRO-1 | — | Operational continuity and disaster recovery across four sites |
ISO 37001 (Anti-Bribery) | 205-1, 205-2, 205-3 | G1-3 (Corruption Prevention) | 510a.1 | UNGC Principle #10 and the Improper Solicitation and Graft Act |
ISO 37301 (Compliance) | 2-27, 419-1 | G1-1 (Business Conduct) | 510a.2 | Integrated management of legal compliance |
FDA 510(k) | 416-1, 416-2 | S4-5 | HC-MS-250a.1 | U.S. pre-market notification for medical devices |
CE Marking + EU MDR | 416-1, 416-2 | S4-5 | HC-MS-250a.1 | EU Medical Device Regulation — complete transition upon entry into force in May 2025 |
MDSAP | 416-1 | S4-5 | — | Integrated audit across Australia TGA, Brazil ANVISA, Canada HC, Japan PMDA, and U.S. FDA |
MFDS GMP | 416-1 | S4-5 | — | Good Manufacturing Practice for medical devices |
NMPA | 416-1 | S4-5 | — | China medical device licensing (i-SENS Jiangsu) |
PMDA QMS | 416-1 | S4-5 | — | Japan conformity assessment |
CDSCO | 416-1 | S4-5 | — | India medical device licensing (i-SENS BIOSENSORS INDIA) |
7. Certification Governance and Renewal System (ESRS 2 GOV-2)
The Company integrates and manages the effective dates, expiry dates, renewal-responsible persons, and internal-audit schedules of 14 certifications and licenses through the Certification Management Register under the Ethics Management Office, automatically triggering renewal procedures 90 days before expiry. ISO certifications are subject to annual surveillance audits and renewal audits every three years; for FDA, CE, MDSAP, and other medical device licenses, immediate notification and re-assessment procedures are operated whenever changes occur.
2026 renewal schedule: ISO 45001 (expired August 2025; renewal in progress) and ISO 13485 (renewal completed April 2026). With the new acquisition of ISO 37001 and ISO 37301 in April 2025, the integrated ISO certification system covering governance, ethics, and compliance has been completed, and from this fiscal year, the Company's certification portfolio is at a level commensurate with global leading companies in the medical device industry.
8. Key KPI Summary (2025)
Area | Key KPI | 2025 Actual | Global Alignment |
Certification portfolio | Number of ISO certifications held | 7 | ESRS 2 GOV-2 |
Certification expansion | New ISO certifications in 2025 | 2 (37001 and 37301) | UNGC #10 |
Medical device licensing | Number of countries with global licensing | 7 (FDA, CE, MDSAP-5 countries, MFDS, NMPA, PMDA, CDSCO) | GRI 416-1 |
Governance | Certification-expiry incidents | 0 cases | ESRS 2 GOV-2 |
Quality outcome | Product recall cases | 0 cases | GRI 416-2 |