Quality all the way
Our commitment to facilitate and support the best outcome for IVF clinics is a cornerstone in our work.
At the Vitrolife Group, we all work to achieve the same goal, whatever our role – to help couples fulfil the dream of having a healthy baby. To do this, we aim to deliver the best products for the entire IVF journey that have consistent performance and guaranteed quality.
We maintain our focus on quality throughout the company, from initial development through to production, distribution and customer support. We have considerable knowledge of the IVF field, with highly qualified and experienced employees. We also perform extensive research, and collaborate closely with many external partners.
The four cornerstones of our quality processes
To provide an unbroken chain of innovative high-quality products that ensure optimal care every step of the way. We focus on quality from initial research and development to production, distribution and clinical & scientific support.
1. Following industry standards and beyond
Our products are classified as medical devices. Medical devices are held to specific standards (or laws) unique to each specific region. In genetic services we have quality accreditations of genetic laboratories, for instance CLIA accreditation in the US.
Learn more about industry standards
2. Quality throughout production process
All Vitrolife products are subjected to a comprehensive quality control program designed for human embryos. Our customers must know that they can rely on our products and this is guaranteed through extensive testing and high lot-to-lot consistency.
Learn more about our quality program
3. Controlled distribution process
Order handling, storage and distribution have been perfected over many years to ensure product integrity and reliable delivery. Since we ship products that demand cold storage, from our production sites in to clinics globally, we have developed packaging and control mechanisms, like temp tracers, to support this.
Learn more about our distribution process
4. Superior clinical & scientific support
Our products come with knowledge on how to optimise the IVF process. A culture system is not only what equipment and consumables we use during the procedure, but also how we work and control the environment we work in. Vitrolife has a vast network of employed embryologists globally, holding the knowledg and we have highly trained and accredited genetic counsellors supporting customers in interpreting the genetic tests results.
Learn more about clinical supportProduct design and quality that make a difference
Our deep insight into both embryo physiology and how to run an IVF clinic helps us to design user-friendly products that fully meet the functional needs of performing IVF.
This insight has also guided us in developing sophisticated highly relevant testing of our products. Our tests go well beyond regulatory demands, with narrow acceptance levels to ensure high performance and the best results for our customers.
We do this because we know our approach is critical to achieving the primary goal: to fully support embryo development.
We have unique competence in testing, which is performed in-house to maintain full control and to ensure that we can carefully track the history of each released product. Our customers must know that they can rely on our products, and this is guaranteed through extensive testing and high lot-to-lot consistency.
In close relationship with our customers
We always listen to our customers, whatever their needs – large or small. All customer cases are handled by a group of experts who determine how specific needs can be met and how the input can be used to further improve our products.
We never rest our case and always strive to deliver beyond expectations.
Contact us
Following industry standards and beyond
Medical devices are held to specific standards (or laws) unique to each specific region. The requirements for documentation for medical devices are different from the requirements for medicinal products and diagnostic products. Product approval is required in regulated markets in which the products will be sold.
- Regulatory Bodies establish laws and regulation in specific regions
- Establishes standards to approve the ability to market a device
- Establishes certifications to standardise aspects fo manufacturing and quality
Quality accreditations of genetic laboratories help us to ensure that our laboratories are run as per the highest standards in the industry.
In Vitro Fertilisation (IVF) vs. In Vitro Diagnostics (IVD) – What is the intended use?
IVF labware refers to medical plastic devices specifically designed and tested for use in In Vitro Fertilisation. These products are used in fertility clinics and laboratories during various stages of the IVF process. Meeting all safety and performance requirements of the Medical Device Regulation, MDR, these products are approved for the handling of gametes and embryos for assisted reproductive technology.*
IVD stands for In Vitro Diagnostics. It refers to medical devices and equipment used to analyse patient samples (such as blood, urine, or tissue) outside the human body.**
Regulations
The two product groups are approved under distinct requirements, following separate directives and regulations. The regulatory requirements depend on the risk classification based on the intended use of the product considering patient safety.
What does this mean?
Only gametes and embryos examined in IVF labware are approved to be reimplanted into the body. Gametes and embryos being in contact with IVD products should not be reintroduced into the body.
Correct product labelling
Make sure that the label of the labware is marked with MD and not IVD. The MD mark assures that the product is approved in line with the MDR.
Also look for a four-digit number displayed next to the CE mark indicating that a Notified Body has assessed the product compliance. If a four-digit number is missing, the product is self-assessed by the manufacturer meaning there is no verification of the compliance with applicable regulations. IVF labware has a risk classification that requires a Notified Body.
Why you should only use IVF certified plastics
The quality of plastic equipment can be detrimental to IVF outcomes. This blog post outlines why you should only use IVF certified plastics.
Read blog postControlled distribution process
Order handling, storage and distribution have been perfected over many years to ensure product integrity and reliable delivery all the way to your clinic.
- Lots are released from production to distribution by our QA Team.
- A Certificate of Analysis is supplied with every product.
- Guaranteed, unbroken cold-chain is ensured for media products through passive coolers and TempTracers.
- Unique shipping ID secures the control and tracking of every package.
Superior clinical & scientific support
Our products come with knowledge on how to optimise the IVF process. A culture system is not only what equipment and consumables we use during the procedure, but also how we work and control the environment we work in. Vitrolife has a vast network of employed embryologists globally, holding the knowledg and we have highly trained and accredited genetic counsellors supporting customers in interpreting the genetic tests results.
Advancing clinical excellence together
Products must be adapted to fit the unique needs and realities of your laboratory and clinic. While the Vitrolife product portfolio is designed for comprehensive utility, there may be times when customisation is beneficial. Peer discussions often offer valuable insights. This is where the Vitrolife Academy steps in - a global network of Vitrolife IVF specialists dedicated to providing clinical support to IVF clinics. The Academy emphasises the holistic product and procedural solutions that Vitrolife offers, with the goal of enhancing efficiency and improving clinical outcomes.
Learn more about Vitrolife AcademyTraining at your convenience – online and onsite
Vitrolife Academy focuses on providing workshops, webinars and educational material to our customers and we strive to help IVF laboratories to work in the most optimal way. Vitrolife Academy offers online training on demand, a complement to our other courses and workshops, to deepen your knowledge.
Request account