Embryo transfer device
In Context
Embryo transfer is a crucial step in the In Vitro Fertilisation process. Advancements in embryo transfer systems have greatly enhanced precision, safety, and patient comfort.
Key innovations, including ultrasound-guided transfers, electromagnetic tracking, and soft, flexible catheters, help ensure that embryos are optimally placed within the uterus with minimal disruption.
Additionally, pressure-controlled delivery systems and AI-driven data with real-time monitoring further improve the effectiveness and safety of the procedure, significantly increasing the chances of a successful pregnancy.
The Challenge
Premium Fertility selected Perdigó to support the testing of its first-generation embryo transfer device prior to regulatory submission.
Device Verification Testing requires in-depth understanding of both the specification and the risks associated with the device, whether these derive from its design, manufacturing or use.
Comprehensive planning and documentation, rigorous execution of the test protocols, and careful evaluation of the results are essential to demonstrate safety and performance.
Perdigó's Approach
Perdigó has developed test and evaluation protocols under its ISO 13485-certified Quality Management System.
The comprehensive series of tests, experiments, and evaluations have been conducted to ensure that Premium Fertility’s device meets specification, mitigates risks appropriately and complies with regulatory requirements. These have included:
- Robustness: assessment of the device under both typical and extreme mechanical stress conditions. These tests ensure the integrity and safety of the device during use.
- Mechanical properties: characterisation of the mechanical properties of specific device components, including flexibility and tensile strength. When these parameters meet specification, the product performs consistently and reliably even in challenging anatomies, ensuring the best patient outcomes. ISO 9626.
- Durability: verification that the device can perform through its life by accelerating the product’s ageing in climate chambers or through cyclical loading.
- Biocompatibility: verification of materials’ biocompatibility according to ISO 10993 and ASTM F88. This prevents adverse reactions caused by toxicity, irritation or allergic reactions. Note that this test is performed by a partner of Perdigó.
- Manufacturing quality: control and characterisation of production consistency using calibrated metrology and microscopy equipment. This practice identifies defects early, preventing costly recalls and design changes.
- Packaging robustness: test the sterile packaging’s seal integrity and peeling force under ASTM F88/88M-21 standard. This ensures that the device will maintain sterility until it is used.
Delivered Value
Device verification testing is an essential aspect of medical device development.
Perdigó has provided Premium Fertility with well-documented test protocols and reports that support the device’s safety and performance.
The fact that these were produced under Perdigó’s ISO 13485-accredited Quality Management System ensures that devices have good traceability, test equipment is calibrated, and documentation is accurate.
As a result, Premium Fertility is pursuing the successful regulatory submission and market entry of its embryo transfer device.
