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Compliance

Gynaia develops Software as a Medical Device (SaMD) in accordance with internationally recognized quality standards
and applicable medical device regulations.
 
Our quality management system and product development processes are designed to ensure patient safety,
regulatory compliance, and continuous improvement throughout the product lifecycle.

 

Regulatory Framework

Our products are developed in accordance with applicable international regulations and standards, including:

Regulations:

  • EU Medical Device Regulation (EU) 2017/745 (MDR)
  • UK Medical Devices Regulations 2002 (as amended)

Harmonized / Recognized Standards: 

  • ISO 13485:2016 - Medical Devices Quality Management System
  • ISO 14971:2019 - Application of Risk Management to Medical Devices
  • IEC 62304 Medical Device Software - Software Life Cycle Processes
  • IEC 82304-1 - Health Software - General Requirements for Product Safety
  • IEC 81001-5-1 - Health Software Security

Quality Management System

Gynaia operates a certified Quality Management System (QMS) that governs the design, development, validation, maintenance and post-market surveillance of our medical device software.

ISO Certificate MD830471 - 001

           ISO 13485:2016 Certified ( ISO Certificate MD830471 - 001.png)

Current Certifications

Gynaia has obtained the following certifications. 

  • MHRA Class I certification for ADNEX

The device listing is available on the UK PARD website.

Product Certifications & Registrations

United Kingdom

Following Products are registered with the UK MHRA:

ADNEX2

EPC

The public device registration can be consulted via the UK MHRA Public Access Registration Database (PARD).

European Union

Our products are undergoing conformity assessment under the EU Medical Device Regulation (MDR). Product-specific certification status is provided on the individual product pages. 

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 info@gynaia.com.

Translations

If you require the IFU in another language, translations can also be provided upon request.

Please email us at info@gynaia.com 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:
info@gynaia.com