Professional Certification

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.

EUSTM Academy
PCSaMD
Professional certification award
Assessment
Two pathways
Global Community
60+ countries
Credential
PCSaMD postnominal
Validity
Annual renewal
EUSTM Global Network
EUSTMEUSTM AcademyEUSTM ConsortiumCanadian Society for Translational MedicineAustrian Society for Translational Medicine

Certification Benefits

When the software is the device, the rules change. Software as a medical device and AI-enabled technologies are the fastest-growing corner of medtech — and the PCSaMD title recognises the professionals who know how to take them through regulation and keep them safe in clinical use.

1Use the PCSaMD postnominal title on your CV, LinkedIn, and professional correspondence — a permanent, portable mark of recognised expertise.
2Demonstrate your competency in SaMD qualification, classification, and lifecycle compliance under EU MDR/IVDR and international frameworks.
3Signal your expertise in AI-enabled medical technologies — clinical validation of algorithms, change management, and post-deployment performance monitoring.
4Strengthen your profile for roles in digital-health and AI companies, device manufacturers, notified-body-facing teams, and regulatory consultancies.
5Increase your visibility for senior roles in digital-device regulatory affairs, software quality, and AI governance.
6Stand out in a competitive global job market with a credential from a European scientific society — in a field shaped by European regulation, from the EU MDR to the EU AI Act.
7Receive an official PCSaMD certificate issued by the EUSTM Academy under EUSTM accreditation.
8Hold a verifiable credential that employers and collaborators can confirm at any time.

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:

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 Experience Pathway, is a CV and portfolio-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

CategoryInitial FeeRenewal
High-income countries€350€300 / year
All other 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 Application

For further information, please contact the EUSTM Academy at [email protected].

Disclaimer: PCSaMD is an independent professional certification awarded by the EUSTM Academy and accredited by EUSTM. It is not equivalent to an educational degree or state-regulated qualification, and is granted solely on the applicant's professional profile as assessed by the EUSTM Academy Educational Board.