Modern system
for MedTech
Comprehensive solution for medical device manufacturers.
Discover our modules
eDMS
Document management.
Implementation
Implementation process in 4 steps.
Analysis
Understanding needs.
Configuration
System customization.
Migration
Data transfer.
Training
Team workshops.
Full connection control
From requirement to test and risk.
Our philosophy
Quality built into the process.
No paper
100% digital processes.
Automation
Less manual work.
Compliance
Always audit-ready.
Supported Standards
ISO 13485
Quality Management
Quality management systems.
ISO 14971
Risk Management
Risk management.
IEC 62304
Software Lifecycle
Medical software.
GAMP 5
Validation
System validation.
21 CFR Part 11
Electronic Records
Electronic signatures (FDA).
GDPR / HIPAA
Data Privacy
Szyfrowanie i ochrona danych osobowych.
Secure Architecture
Built with security in mind.
Infrastructure
AWS Frankfurt (EU). Fizyczna separacja danych. Dedykowane VPC dla każdego klienta Enterprise.
Encryption
Klucze szyfrujące zarządzane przez KMS. Dane zaszyfrowane w spoczynku i w ruchu (TLS 1.3).
Backups
Point-in-time Recovery (PITR) - odtwórz dane z dowolnej sekundy z ostatnich 30 dni.
"First 5" Pilot Program
We are looking for 5 companies to implement the system first in exchange for roadmap influence and preferential terms.
Ready to start?
Zacznij od darmowej konsultacji. Pokażemy Ci, jak w 30 minut zautomatyzować procesy, które dziś zajmują dni.
Have questions?
Let's talk about your processes.
Not sure which package to choose? Or maybe you need a custom integration? Our engineers will be happy to help.