Legislation & Quality

Quality standards mean quality assurance. At Gynem, we operate according to a strict set of guidelines that inform and regulate what we do and how we do it. These come both from within our organisation and without—as self imposed standards checked by regular inspection and as demanding legislation at the EU and state levels.

 

 
Mrazkovi

The specifics of legislation concerning assisted reproduction vary from country to country within the EU. However, a directive defining quality and safety standards for the proper handling of human tissue and cells—including eggs, sperm, and embryos—is in effect for all member states. In the Czech Republic, while the legislation pertaining to these matters takes its instruction from this directive, the law is considerably more exacting and imposes health and safety controls on nearly every aspect of a fertility clinic’s operations.

Certifikat

Areas of regulation include ART procedures themselves, laboratory workspace and materials, documentation, and even air quality. Specific regulations for the protection of egg donors, recipients, and embryos are also in place. As proof of compliance with these strict requirements, we are licensed by the State Institute for Drug Control (SÚKL), which audits our clinic every two years, and we also hold ISO 9001 certification, confirming that our clinical, laboratory, and management processes meet internationally recognised standards of quality, consistency, and continuous improvement.

Together, these internal and external safeguards foster a culture of exceptional quality at Gynem that directly benefits our clients. Combined with the commitment and attentiveness that come with being a family-owned clinic, the result is a fertility centre of truly high calibre.

 
sukl

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