PCSaMDProfessional Certification in Software as a Medical Device & AI
A professional credential offered by EUSTM Academy, an educational initiative of the European Society for Translational Medicine (EUSTM) — recognising the professionals who bring medical software and artificial intelligence safely through regulation and into clinical use — SaMD qualification, lifecycle compliance, and the oversight that keeps AI-enabled devices safe in the real world.
Awarded by the EUSTM Academy — an educational initiative of the European Society for Translational Medicine (EUSTM), a non-profit scientific society registered in Vienna, Austria (ZVR 629427022), active in more than 60 countries since 2013.
Certification Benefits
The EUSTM Academy Professional Certification in Software as a Medical Device & AI provides a structured way to demonstrate your knowledge, experience and professional contribution in this specialist area. As a certified professional, you can:
EUSTM Academy certification is designed to strengthen professional positioning and provide evidence of assessed competence. Recognition and acceptance remain subject to the independent requirements of employers, institutions, regulators and other professional bodies.
Who Should Apply?
PCSaMD is designed for professionals who build, regulate, or validate medical software and AI-enabled technologies. If one of these describes you, you are eligible to apply:
- Regulatory and quality professionals working with SaMD and AI-enabled devices
- Software engineers and AI/ML specialists in medical technology
- Digital-device product and programme managers
- Clinical-validation and algorithm-performance professionals
- Software quality, risk, and cybersecurity specialists in healthcare
- Clinicians leading AI implementation and oversight
- Notified-body, authority, and assessment professionals
- Consultants supporting SaMD and AI regulatory strategy
Application process
Applying is straightforward. Complete the secure online PCSaMD application form and upload your CV — your submission goes directly to the EUSTM Academy Educational Board.
The Board reviews every application and assigns one of two pathways based on your background and experience. Category 1, the Professional Experience Pathway, is a CV- and experience-based evaluation for established professionals — no examination required. Category 2, the Examination Pathway, is for those earlier in their career or moving into the field, with certification granted on passing a qualifying online examination (results within two weeks). If you are unsure which applies, the Board assigns your category after reviewing your application.
Once your pathway is confirmed, you sign the Certification Conditions Form and pay the applicable fee. Your PCSaMD certificate is then issued, together with the right to use the post-nominal title.
PCSaMD Certification Fee
| Category | Initial Fee | Renewal |
|---|---|---|
| High- & middle-income countries | €350 | €300 / year |
| Low-income countries | €250 | €200 / year |
Country tiers follow the World Bank income classification. Annual renewal confirms your continued active engagement in software as a medical device and AI and your commitment to the EUSTM Code of Professional Conduct.
Begin your PCSaMD certification journey
Apply online in minutes — complete the form and upload your CV — to begin your formal recognition as a certified software as a medical device and AI professional.
Start Your ApplicationFor further information, please contact the EUSTM Academy at [email protected].
Disclaimer: PCSaMD is an independent professional certification awarded by the EUSTM Academy, the education division of EUSTM. It is a non-statutory professional-society credential and is not an academic degree or state-regulated qualification, and is granted following individual assessment by the EUSTM Academy Educational Board through either the Professional Experience Pathway or the Examination Pathway.