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