Software for medical technology that passes the MDR.
From idea to certified medical device. We build software for MedTech and HealthTech companies, including architecture, risk analysis and conformity documentation.
Medical technology & MedTech
Medical-device software rarely fails on code, it fails on risk analysis, documentation and the protection of health data. We build MedTech and HealthTech software so it passes the EU MDR conformity assessment, from intended use to the technical documentation. Our founder was the technical architect of an approved Class I medical device with thousands of patients.
- ✓Medical device software (Class I and up)
- ✓EU MDR conformity documentation
- ✓Risk analysis & usability
- ✓Secure health-data processing
- ✓Patient apps & portals
- ✓Pentest & audit preparation
Intended use & classification
A clear definition of purpose and risk class as the basis for all MDR documentation.
Risk analysis (ISO 14971)
Systematic risk assessment and measures, documented for the conformity assessment.
Auditable architecture & verification
Secure, traceable software with verification and traceability.
Secure health data
Processing of special data categories under GDPR, encrypted and access-controlled.
Technical documentation (MDR)
Complete technical documentation for the EU MDR conformity assessment.
Pentest & audit readiness
Preparation for penetration tests and the notified body review.
Proven, not claimed.
We’ve built it ourselves
Our founder was the technical architect of a certified Class I medical device with thousands of patients.
0 findings in a pharma pentest
The platform passed a global pharma company’s penetration test with zero findings.
Regulation as everyday work
MDR, health data, GDPR: not new territory, but daily practice.
From idea to audit.
Concept & intended use
What should it do, which class?
Architecture & risk analysis
Built secure, cleanly documented.
Development & verification
Auditable, tested, traceable.
Conformity & audit-readiness
Ready for the conformity assessment.
FAQ
Does Pyinv build certified medical devices?
Do you handle MDR documentation?
Which risk classes do you cover?
Do you work with our notified body?
How do you protect health data?
Do you also build patient apps?
Got a medical device in mind?
We’ll bring it safely to conformity. The intro call is free.
Request a project →