Consultation on
Software Regulatory
Affairs
Software Regulatory and Privacy affairs
are our everyday business!
Any software which is used as standalone medical product or as part of a medical product, should be developed under specific regulatory framework.
Our specialists will help you understand, implement and conform to regulatory requirements. Through our guidance, you will turn your idea into a certified software.
Expertise
Our team consists of quality & security specialists with extensive experience in:
ISO 13485
Medical devices Quality System
MDR
Medical Device Regulation
IVDR
In-Vitro Diagnostics Medical Device Regulation
21 CFR Part 820
Quality System Regulation - FDA
IEC 62304
Medical device software
ISO 14971
Risk management
IEC 62366-1
Usability engineering
IEC 82304
Health software
IEC 60601
Safety (PEMS)
HIPPA
Security & Privacy Rules
GDPR
General Data Protection Regulation
Cybersecurity (FDA)
Guidelines on Cybersecurity