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
Teamwork
Integrity
Accountability
We deliver what is agreed on and always on time.
Respect
Human
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
Anna Gumenyuk
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 – Quality Management System (QMS)
- EN 62304:2006 – Medical Device Software Life Cycle Processes
- EN ISO 14971:2019 – Risk Management
- 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
- EN-IEC 62366-1:2015 – Usability Engineering Medical Devices
- EN ISO 18113-1:2011 – Information Supplied By Manufacturer
- EN ISO 15223-1:2016 – Use Symbols For Medical Device Labelling
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.