ISO 13485
Quality Management
Our quality management system ensures every process — from design to deployment — meets the requirements for medical device manufacturing.
Evidence & Compliance
Built to the highest standards — so you can focus on care.
In health tech, trust isn't optional. Our products are developed, tested, and maintained under rigorous regulatory and quality frameworks across the EMEA region.
ISO 13485
Quality management
G-BA
Compliant
GDPR
By design
Certifications & Standards
Regulatory frameworks we work within
Every product we ship meets or exceeds the requirements below. We do the compliance work so our partners don't have to.
GDPR Compliance
Data Protection
Data protection is built into our architecture from the ground up — not bolted on afterwards. We comply fully with the EU General Data Protection Regulation.
IEC 62304
Software Lifecycle
Our software development follows IEC 62304, covering the full medical software lifecycle from planning through maintenance.
G-BA Quality Assurance
QS-V TmHi
inCareNet HF meets the G-BA quality assurance requirements for telemonitoring in heart failure, making it eligible for statutory reimbursement in Germany.
HL7 / FHIR
Interoperability
Our systems are built on international healthcare interoperability standards, ensuring seamless integration with existing clinical infrastructure.
Data Security
Security is foundational, not an afterthought.
Patient data is among the most sensitive information there is. Security is built into every layer of what we build.
- Hosted in GermanyCertified cloud infrastructure within German jurisdiction.
- End-to-end encryptionAll data encrypted in transit and at rest.
- Role-based access controlsGranular permissions across all platforms and institutions.
- Regular security auditsRoutine penetration testing and independent security reviews.
- Incident response proceduresFormal processes for rapid detection and resolution.
Our commitment
Patient data stays in Germany.
Certified cloud infrastructure within Germany — subject to German law, German data protection standards, and regular third-party audits. Your patients' data never leaves the jurisdiction.
- GDPR by design
- Germany-hosted
- Encrypted end-to-end
- Role-based access