Our medical device software is meeting

EU and US quality and regulatory compliance

CE Marked
EU MDD Class I,
transition EU
MDR Class I

FDA registered
21 CFR Part 820
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

Our medical device software is meeting EU and US quality and regulatory compliance

CE Marked
EU MDD Class I,
transition EU
MDR Class I

FDA registered
21 CFR Part 820
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