Who we are

We believe in assisting clinical specialists with early cancer detection and classification using AI solutions

Our mission

To create a better survival outcome for patients suffering from cancer with the use of AI solutions.

Our vision

To cut the diagnostic turnaround time for Head & Neck cancer with 50% by 2030.

Our company values

Quality

From technical design to customer support; we believe in always striving for the highest possible quality.

Teamwork

We believe in co-developing our AI-solutions with the end-users.

Integrity

What we say is based on what we can do.

Accountability

We deliver what is agreed on and always on time.

Respect

We respect our industry, it’s people and most important: the patient.

Human

Our AI solutions are designed to improve human lives, from caregiver to patient.

Meet our team

Marius Wellenstein

CEO/COO & founder

Jonathan Woodburn

CTO

Tubay Yüceyalçın

Business Development Manager

Felix Dikland

Data Scientist

Dr. Frans van Andel

Market Access Director

Leon Doorn

QA Manager & PRRC

Cyrine Fekih

Data Scientist

Jesse Wiers

Data Scientist Intern

Compliance

Within the EU, software with a medical purpose is considered a medical device and therefore needs to comply with the Medical Device Regulation (2017/745) or the In-Vitro Device Regulation (2017/746). All our AI solutions have to get CE-MDR/IVDR approval and therefore meet all regulatory and compliance requirements.

Standards

Developing software with a medical purpose means having to be compliant against stringent regulations. We use ISO/IEC (international) and EN (European) standards when developing our AI solutions, thus always ensuring we stay compliant against the regulations. By using harmonized standards, we know those standards meet compliance against legislative requirements.

WSK Medical and our associated AI solutions comply with:

  • EN ISO 13485:2016 A11:2021 Quality management systems — Requirements for regulatory purposes
  • IEC 62304:2006/AMD1:2015 Medical device software — Software life cycle processes — Amendment 1
  • EN ISO 14971:2019 Application of risk management to medical devices
  • IEC 82304-1:2016 – Health software – Part 1: General requirements for product safety
  • EN ISO 14155:2020 – Clinical investigation of medical devices for human subjects — Good clinical practice
  • IEC 62366-1:2015/COR1:2016 – Part 1: Application of usability engineering to medical devices — Technical Corrigendum 1
  • ISO 20417:2021 – Information Supplied By Manufacturer
  • EN ISO 15223-1:2016 Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
  • EN IEC 81001-5-1:2022 – Health software and health IT safety, effectiveness and security

For all compliance related queries or to request a recent copy of our CE certification, please contact compliance@wskmedical.org. Under the MDR/IVDR, a Person Responsible for Regulatory Compliance (PRRC) has to be appointed for all regulatory and compliance matters. At WSK Medical this is Leon Doorn from QAIR.io.