What it is:

• An internationally recognized standard for quality management systems (QMS).

Why it matters:

• Ensures the clinic follows a structured approach to improve processes and maintain quality.
• Builds trust with patients and stakeholders by showing commitment to continuous improvement.
• Enhances operational efficiency and reduces errors.
• It is a prerequisite for partnerships with insurers, research institutions, or international collaborators.

Having certification for all our services, confirms that Medimall IVF Clinic, beyond being a specialized assisted reproduction clinic, it is also a modern, high-quality medical center. 

What it is:

• A legal requirement for clinics in the EU that handle human tissues and cells, including gametes and embryos.

Why it matters:

• Ensures traceability, donor consent, safety, and quality in all procedures involving human tissues.
• Mandatory for operating legally in the EU; non-compliance can lead to closure or penalties.
• Provides confidence to patients regarding biological safety and ethical handling of their tissues.

Medimall IVF Clinic with its own Donorbank, is licensed according to the EU-Tissue Directive from the year 2018. This means that we can receive and deliver eggs, sperm and embryos in all EU countries. 

What it is:

• Required for clinics or labs involved in handling human cells/tissues intended for implantation, especially if materials are transported to or from the U.S.

Why it matters:

• Demonstrates adherence to U.S. safety and traceability standards for human cells and tissues.
• All donors are screened and tested to meet FDA requirements, ensuring that gametes are free from communicable diseases: especially important when using donor sperm, eggs, or embryos.
• Following FDA-mandated protocols for screening, testing, and storing gametes and embryos, minimizes the risk of contamination, infection, or misuse.
• Important for international patients (medical tourism), collaborations, or if importing/exporting biological materials (e.g., donor eggs, sperm).
• Reduces legal risk when working across borders and builds international credibility.

Medimall IVF Clinic is officially registered with the U.S. Food and Drug Administration (FDA) as a bank for human cells, tissues, and cellular and tissue-based products (HCT/Ps). Our clinic is authorized to process and distribute donor gametes that fully comply with U.S. law—an essential assurance for U.S.-based patients or those planning to transfer gametes internationally. So if you’re traveling from the U.S. or planning to use reproductive materials across borders, FDA registration guarantees compliance with international regulations and peace of mind.

FEI (Facility Establishment Identifier) Number: 3035691617