Compliance

Regulatory Framework

Gynaia operates under the following regulatory frameworks:

• EU Medical Device Regulation (MDR)
• UK Medical Devices Regulations
• ISO 13485:2016 Quality Management System
• ISO 14971:2019 Risk Management
• IEC 62304 Medical Device Software

Quality Management System

Our QMS ensures consistent quality and regulatory compliance across all services.

Certifications

• CE Mark for medical device software
• UKCA Mark for UK market
• ISO 13485:2016 certification

Data Protection

We comply with:

• GDPR requirements
• UK Data Protection Act 2018
• Healthcare data protection standards

Contact

For compliance inquiries: