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.

Upcoming Certifications

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

Regulatory Documents

Access essential documentation for our software as medical device:

ADNEX Instructions for Use (IFU)
ADNEX Release Notes

Paper Copy Availability

The Instructions for Use (IFU) are available as a downloadable PDF, which can be easily printed for your records. This ensures quick and convenient access to the most up-to-date version. In accordance with regulatory requirements, a printed copy can be provided upon request. If you require a paper copy, please contact us at .

Translations

If you require the IFU in another language, translations can also be provided upon request. Please email us at to obtain a translated version.

Data Protection

We comply with:

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

Contact

For compliance inquiries: