Compliance

Subtle Medical is a manufacturer of radiology image enhancement products that are Software as a Medical Device (SaMD) with Artificial Intelligence/Machine Learning (AI/ML) algorithm components. Subtle Medical has a Quality Management System (QMS), which includes an Artificial Intelligence Management System (AIMS), with the scope for the design and development, manufacture, installation and servicing of software products for the area of medical imaging enhancement. Subtle Medical defines its commitments in our Quality Policy and AI Policy.

Quality Policy

Subtle Medical, Inc. is committed to developing safe, reliable, and innovative software products to improve the efficiency and quality of medical imaging. Subtle Medical shall maintain an effective and compliant quality management system and market products that meet or exceed applicable regulatory requirements.

AI Policy

Subtle Medical, Inc. is committed to developing safe, responsible, and ethical artificial intelligence (AI) software products to improve the efficiency and quality of medical imaging. Subtle Medical shall maintain and continually improve an effective and compliant AI policy and develop products which meet or exceed applicable AI regulations, standards, and guidances.

Reference: LBL100 Rev A.0

Security Audits

SOC 2 System and Organization Controls 2

(Annual SOC 2 Type II + HIPAA)

Medical Device Certifications

Subtle Medical is independently validated through the following certificate programs:

  • EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes (Valid until 2027-07-12)
  • ISO/IEC 42001:2023 AI management systems (Valid until 2028-07-17)
  • EN ISO 13485:2016 / MDSAP (AU, BR, CA, JP, US) Medical Device Single Audit Program* (Valid until 2027-07-12)
  • MDR 2017/745 – Annex IX Medical Device Regulation* (Valid until 2028-07-14)

*Note: By complying with MDSAP in countries participating in this program and EU MDR 2017/745 CE marking, Subtle Medical fulfills an audit requirement needed to register products in those markets. Contact your sales representative to confirm availability of products in your country.

The following are notable standards which Subtle Medical is fully compliant with:

  • ISO 14971:2019 Medical devices – Application of risk management to medical devices
  • IEC 62304:2006 Medical device software — Software life cycle processes