Quality is our Foundation

Global compliance, local accountability

Certificate of analysis

Quality

At Gynotec, quality is embedded in every stage of our product lifecycle — from design and development to manufacturing, distribution, and customer support. Our commitment to the IVF field demands precision, safety, and consistency, which we uphold through rigorous quality control and continuous improvement.

Batch Release

All products undergo thorough testing before market release, and batch-specific Certificates of Analysis are available for download to ensure full transparency.

Download CoA →

Regulatory Compliance

Gynotec operates under a certified ISO 13485:2016 quality management system and complies with the European Medical Device Regulation (MDR). In addition, FDA 510(k) clearance has been obtained, and we maintain local registrations where required to ensure global regulatory compliance.

ISO 13485:2016 Certification for Quality Management

  • ISO 13485:2016 certification for quality management systems in medical devices.
  • Successfully complied with Medical Device Regulation (MDR).
  • Over 25 years of ISO-certified compliance.

Compliant with Medical Device Regulation (MDR)

  • MDR CE marked medical devices, ensuring conformance to EU health and safety standards.
  • FDA 510(k) clearance, authorizing U.S. market access.
  • Product registration in additional countries, ensuring local compliance worldwide.