Advancing Fertility Care Through Real-World Clinical Evidence
Quality and safety are at the heart of everything we do at CooperSurgical. That commitment does not end when a product reaches the market—it extends across the product’s entire lifecycle. Post-Market Clinical Follow-up (PMCF) activities are one of the ways we uphold that commitment, and it is made possible through meaningful collaboration with IVF clinics around the world.
For clinical, scientific, and laboratory leaders focused on clinical excellence, regulatory compliance, and high-quality patient care, participation in PMCF activities offer an opportunity to contribute retrospective clinical data that support the generation of real-world clinical evidence used in the ongoing evaluation of medical devices in reproductive medicine.This article examines what PMCF involves, why it matters, and what participating clinics have experienced firsthand.
What Post-Market Clinical Follow-up Involves
PMCF is an established component of post-market surveillance and clinical evaluation activities that supports the ongoing monitoring of product safety and performance. Rather than treating regulatory approval as a finish line, PMCF represents a starting point for continuous clinical evidence generation and evaluation throughout the product lifecycle.
In practice, our proactive PMCF activities typically involve the collection and retrospective analysis of routinely collected clinical data. This approach generates valuable real-world evidence while minimizing disruption to clinic workflows. Partner clinics are not asked to overhaul their workflows or divert resources from patient care. Instead, they contribute data that already exist as part of their day-to-day practice.
This evidence serves several purposes at once:
- It supports compliance with applicable regulatory requirements.
- It contributes to product lifecycle management and ongoing clinical evaluation.
- It expands the body of real-world evidence, supporting the identification of opportunities for continued learning and evidence-based decision-making.
The result is a collaborative process that delivers value across the board—for the clinics that participate, for the professionals who rely on our products, and for the patients they care for.
Why Real-World Evidence Matters
Real-world evidence tells us how a product performs in the settings where it is used, across diverse patient populations and clinical practices. Proactive PMCF activities play an essential role in monitoring ongoing safety and performance in real-world clinical settings that define modern reproductive medicine. By analyzing how devices perform across many clinics and many cases, CooperSurgical can strengthen the evidence base supporting its products and maintain a robust understanding of their performance throughout the product lifecycle.
Partner clinics are central to this process. When a clinic shares its clinical data, it reinforces its role as a valued partner in supporting innovation, quality, and patient care within the fertility community. This is not a onedirectional relationship. Through this collaborative effort, participating clinics help strengthen the clinical evidence supporting medical devices used in reproductive medicine while contributing to the advancement of scientific knowledge within the field.
A Straightforward, Collaborative Process
We understand that clinical and laboratory leaders operate under constant pressure to manage throughput, control costs, and maintain the highest standards of patient care. Adding a new commitment to an already demanding schedule is not a decision taken lightly.
That is why we have designed our PMCF process to be straightforward and collaborative. Our team provides clear, efficient support at every stage, and the retrospective nature of the work means clinics can participate without disrupting their routine operations. The goal is simple: to make meaningful scientific contributions accessible, not burdensome.
The experiences of participating clinics reflect this design. Across geographies and clinic types, the feedback reflects a consistent experience – participation is well supported and straightforward.
What Our Partners Say
The most compelling case for PMCF participation comes from the professionals who have experienced it firsthand. Their perspectives, drawn from respected clinics across three continents, share a consistent theme: rigorous science delivered through a supportive, streamlined partnership.
”The PMCF project reflects a strong and well-established collaborative partnership, providing clinically relevant insights that can be effectively integrated within existing practice frameworks. The project’s methodological rigor and scientific approach supported the generation of high-quality data that strengthens quality metrics and patient-cantered outcomes. Participation in initiatives such as this is essential for advancing evidence-based practice in reproductive technology.”
— Yousef Alhlou*, PhD, Scientific Director, Fakih IVF Group and First IVF Group, UAE
“As a partner in the PMCF project, we found the process simple and easy to implement. The company’s support was clear and efficient, making participation a smooth experience. This initiative gave us the chance to contribute to valuable real-world clinical evidence that is valuable for clinicians and patients alike.”
— Lianos Medrano*, PhD, Previous National Coordinator of Laboratories, IVF-Life, Alicante, Spain
“Participating in the PMCF project was a smooth and rewarding experience. The process was very straightforward, and we felt fully supported throughout by the company’s team. It provided us with the opportunity to contribute to meaningful real-world clinical evidence while adding value to our daily practice. We believe this project reflects a genuine commitment to quality and patient safety, and we would encourage other clinics to participate.”
— Amparo Mifsud-Giner*, PhD, Senior Embryologist, IVIRMA Valencia, Spain
“As Scientific Director, I found the PMCF project simple to implement and very well supported. It allowed us to contribute to valuable real-world data that benefits both clinics and patients.”
— Emma Ebinger, M.Sc., Scientific Director, Adora Fertility & Adora Day Surgeries, Australia
A Commitment That Continues
Proactive PMCF activities reflect CooperSurgical’s ongoing commitment to clinical excellence, quality, patient safety, and continuous product improvement. They not only support regulatory compliance but also serve as a genuine mechanism for advancing the safety and performance of the devices that fertility professionals rely on every day.
By collaborating with IVF clinics to generate real-world clinical evidence, we support ongoing post-market surveillance, clinical evaluation, and improvements that benefit healthcare professionals and patients alike. Every participating clinic contributes to this effort and helps strengthen the evidence base that supports reproductive healthcare professionals and the patients they serve.
Through PMCF activities, CooperSurgical continues to gain valuable insights into product performance and safety in routine clinical practice, reinforcing its commitment to ongoing clinical evaluation throughout the product lifecycle, with the ultimate goal of supporting high-quality patient care.
If you would like to learn more about CooperSurgical’s PMCF activities and their role in generating of real-world clinical evidence that supports ongoing product evaluation and improvement, we invite you to contact our team.
*The individual or affiliated clinic has provided consultancy services for CooperSurgical. No compensation was specifically provided for this testimonial.