Developing Software as a Medical Device (SaMD) requires combining modern agile software engineering with strict medical regulatory compliance. As specialists in medical device and SaMD projects, Glaze Medical guides teams through every critical step from initial concept to market launch.
1. Define a Clear Intended Purpose
Before writing production code, establish a crystal-clear clinical purpose. Define what medical condition or clinical workflow your SaMD addresses, who the intended users and patient populations are, and what specific clinical benefits and medical claims you aim to achieve.
2. Understand Regulatory Requirements Early (EU MDR & FDA)
Healthcare software is heavily regulated. Mapping out EU MDR (Rule 11 / MDCG 2019-11), FDA SaMD guidelines, ISO 13485, and IEC 62304 at the beginning of the project prevents costly architectural rework later.
3. Build a Cross-Functional Team
Successful SaMD delivery brings together software engineering, clinical insight, usability design (IEC 62366-1), cybersecurity, and regulatory/quality assurance expertise working toward shared milestones.
4. Engage Users and Protect Patient Data
Involve clinicians and patients early to validate usability and clinical relevance, while building cybersecurity, encryption, and GDPR data protection directly into the architecture from day one.
5. Agile Development, Verification, and Validation
Agile methods work seamlessly with medical compliance when paired with structured Design Controls (e.g., AAMI TIR45). Comprehensive unit, integration, system, and usability testing prove that your software performs safely and reliably.
6. Technical Documentation & Post-Market Surveillance
Compile traceable evidence in your Technical File for CE marking or FDA submission, and maintain active Post-Market Surveillance (PMS) throughout the software lifecycle. Contact Glaze Medical to kickstart your SaMD journey today.