Professional Certification

PCSaMDProfessional Certification in Software as a Medical Device & AI

A professional credential offered by EUSTM Academy, the professional certification body 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.

EUSTM Academy
PCSaMD
Professional certification award
Assessment
Two pathways
Global Community
60+ countries
Credential
PCSaMD postnominal
Why It Matters

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

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:

Certification Categories

Two pathways to certification

After you submit the PCSaMD Application Form, the EUSTM Academy Educational Board reviews each application and assigns one of two categories based on your background, experience, and qualifications.

1
Category 1

Experience Pathway

For professionals with 3 or more years of relevant medical-software, SaMD regulatory/quality, or AI-in-healthcare experience — CV-based evaluation, no examination required.

  • Background & experience review — relevance and depth across the medical-software and AI lifecycle.
  • Evidence of contribution, regulatory rigour, and the quality of your professional statement.
2
Category 2

Examination Pathway

For early-career professionals or those transitioning into software as a medical device and AI — certification granted upon passing a qualifying online examination.

  • Qualifying online examination covering core SaMD and AI-governance competencies — proctored online and available year-round.
  • Results within two weeks; a pass mark is required to qualify for certification.
Application Process

Five steps to certification

1

Submit Application

Complete the secure online application form and upload your CV. There is no application fee — your submission goes straight to the EUSTM Academy Educational Board for review.

2

Board Review

The EUSTM Academy Educational Board reviews your application and assigns Category 1 or 2.

3

Assessment

Category 1: portfolio evaluation. Category 2: qualifying online examination.

4

Conditions & Fee

Sign the Certification Conditions Form and pay the applicable fee.

5

Certificate Awarded

Receive your PCSaMD certificate and the right to use the postnominal title.

Certification Fees

PCSaMD Certification Fee

CategoryInitial FeeRenewal
High-income countries€400€400 / year
Middle-income countries€325€325 / year
Low-income countries€250€250 / 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 — with no application fee — 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.