Who we are
We believe in assisting clinical specialists with early cancer detection using AI solutions
Our mission
WSK Medical bridges the gap between the medical field and AI by developing easy-to-use, workflow integrated, clinically valuable AI systems for early cancer detection. We do this by translating complex, medical problems into solutions that assist doctors and clinicians in their daily work.
Our vision
Data can create value for assisting in cancer prevention, treatment and care.
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
Global Sales / Business Development Manager
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 solutions are CE certified 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 (international) and EN (European) standards when developing our 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 solutions comply with:
- EN ISO 13485 – Quality Management System (QMS)
- EN 62304:2006 – Medical Device Software Life Cycle Processes
- EN ISO 14971:2019 – Risk Management
- 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 compliant matters. At WSK Medical this is Marius Wellenstein.
