Quality Management System

Legit.Health operates a fully certified Quality Management System (QMS) for the design, development and commercialization of software as a medical device. The product is a Class I medical device CE-marked under MDD (2020), in transition to Class IIb under EU MDR (Rule 11) with notified body BSI.

📋Certified quality management system

ISO 13485:2016

Certified by BSI. Certificate No. MD 792784. Issued August 2024, valid until August 2027.

✅ Certified

Standards the QMS is built on:

• ✅ ISO 13485:2016 (quality management systems), certified by BSI (cert. MD 792784)
• ✅ IEC 62304 (medical device software life cycle)
• ✅ ISO 14971:2019 (risk management)
• ✅ ISO 15223-1, EN 1041, IEC 62366 (labelling, information supplied, usability engineering)

We run the full QMS at qms.legit.health (private access 🔒). The complete documentation (procedures, records and technical file) is available to investors during due diligence.

Scope

We are the legal manufacturer of software as a medical device: a clinical decision support tool for diagnosis support and objective severity monitoring of visible skin conditions, intended for use by healthcare professionals. The QMS covers the full ISO 13485 lifecycle, adapted to a software-only manufacturer.

How the QMS is organised

Twenty-four controlled general procedures (GP-001 to GP-052), grouped by area:

Design and software life cycle

Design, redesign and development · Software validation · Design change control · Product requirements

Risk and clinical

Risk management (ISO 14971) · Clinical evaluation

Post-market and safety

Post-market surveillance · Vigilance system · Feedback and complaints · Non-conformity, corrective and preventive actions (CAPA)

Quality assurance

Quality planning · Internal audit · Data analysis · Documents and records control

Operations and suppliers

Purchases and suppliers evaluation · Provision of service · Traceability and identification · Technical assistance · Infrastructure

People, commercial and data protection

Human resources · Sales · Communications · Documentation translation · Data protection · Security violations · Data privacy impact assessment (DPIA)

Adapted to a software manufacturer

As a software-only manufacturer, a defined set of ISO 13485 clauses do not apply (product cleanliness, sterilization, physical installation, implantable-device and monitoring-equipment requirements). Each exclusion is documented and justified within the QMS.

Why a certified QMS matters

A Notified-Body-certified ISO 13485 system is the prerequisite to sell to hospitals, insurers and pharma, the foundation for the MDR Class IIb transition and the FDA pathway, and a multi-year barrier to entry that earlier-stage competitors have not cleared.