Our software is built for quality and EU & US regulatory compliance
21 CFR Part 11
Following FDA and EMA guidelines for digital health technologies in clinical trials
Certifications & Audits
Audited and approved supplier
to major pharma companies
and hospitals
Certified
ISO13485:2016 Quality Management
System for Medical Devices
ISO27001:2013 Information
Security management
System
Part of SOPs
ISO14155:2020
IEC62304 Software Life Cycle
ISO14971 Risk management
Security & Privacy
GDPR compliance
HIPAA compliance
PIPAA (South Korea)
Regulatory team to expand
to other regions
Regular penetration tests
under OWASP ASVS Checklist
Our software is built for quality and EU & US regulatory compliance
CE Marked
EU MDD Class I,
transition EU
MDR Class I
FDA registered
21 CFR Part 11
Certifications & Audits
Audited and approved supplier
to major pharma companies
and hospitals
Certified
ISO13485:2016 Quality Management
System for Medical Devices
ISO27001:2013 Information
Security management
System
Part of SOPs
ISO14155:2020
IEC62304 Software Life Cycle
ISO14971 Risk management
Security & Privacy
GDPR compliance
HIPAA compliance
PIPAA (South Korea)
Regulatory team to expand
to other regions
Regular penetration tests
under OWASP ASVS Checklist