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Introduction to Medical Device Regulations - MDR

For 30 years medical devices have been governed by the Medical Device Directive (MDD) implemented in EU/EEA in 1993, and there have been quite a few developments in the field of medical devices since then. For instance, apps used as stand-alone products for different medical purposes have become a reality. The general population has become older, patients are more used to finding medical information on the internet, and the beauty industry uses more advanced and invasive techniques than before. These changes, and more, have prompted an update of the control of medical devices for some time. Eventually, the new Medical Device Regulations (MDR) were developed and came into force on May 26, 2021. From this date, all new medical devices and the manufacturer’s quality management system must comply with the MDR. Implementation deadlines for existing devices are dependent on classification and expiry of existing MDD certificates.

Looking at available data on results in IVF, outcome differs widely between clinics and countries. In this blog post Dr. Markus Montag speculates if this could be related to quality and workflow in the constantly developing field of IVF. He also provides valuable tips on how to create a more efficient workflow in your lab and thus gain higher quality

The human embryo is extremely sensitive to stress and surrounding factors. In fact the embryonic stage is the most sensitive stage of the whole life cycle. This is why it is particularly important to use safe and non-toxic products during gamete handling and embryo culture. In this recorded webinar Dr. Christer Silversand will show how you can create optimal culture conditions by understanding the importance of extensive quality testing and using an unbroken chain of quality products.

During the Vitrolife Scientific Symposium at ESHRE 2017, we had the pleasure of listening to three international experts in the field of human IVF sharing their experience in laboratory management, morphokinetics and cryobiology. We are confident that information from these presentations will assist you in not only in improving your workflow, but will help you to maximise the success of each cycle of IVF performed.

A successful IVF treatment is a pregnancy that results in the birth of a healthy child. Many aspects are discussed in order to raise pregnancy rates. An increasingly important parameter to reflect a successful IVF program in today's world of IVF is the time to pregnancy and live birth. In this blog post I will go through some of the critical steps in the IVF procedure and how they can be optimised.

Culture media for IVF can go out of specification during transport for different reasons. This may be detrimental to the product, but not always. In this blog post I will explain what happens to the media when it gets too warm or too cold.

The success of an IVF treatment depends on numerous factors. The patients and the causes of their infertility, the hormone stimulation regimen, culture media, quality and maintenance of equipment and skills of staff are all factors that will influence the outcome. One important factor that can have a detrimental impact on the IVF treatment outcome, but is sometimes overlooked, is the quality of the plastic equipment. 

A question we often get from clinics is for how long time an opened bottle can be used. And if it is possible to aliquot and use the medium until expiry date. In this blog post I make an attempt to answer these and other related questions on safe usage of media.

It is common practice to maintain a temperature of 37 oC during all working and culture conditions in the IVF laboratory. This will allow for an optimal environment for the handling and culture of gametes and embryos. In this blog post I will explain why temperature control in the IVF lab is crucial, what equipment to be measured, when to measure and what to do with the results.  

The quality of air within an IVF lab will inevitably affect embryonic development and therefore has a critical impact on IVF success. Our guest blogger Giles Palmer is a senior clinical embryologist who has supported many IVF labs in improving the air quality. In this blog post he shares his valuable recommendations on how to secure the air quality in your IVF lab.