There is no margin for error in the life science industry. When it comes to the storage of stem cells, therapeutic tissues or highly sensitive drugs, the technical reliability of cryoproducts is inextricably linked to medical success. For patients whose treatment depends on the vitality of a cryopreserved sample, the quality of the technology is vital.
Consarctic®, as a specialized cryotechnology company, has placed this fact at the center of its actions from the very beginning. Our certifications in accordance with EN ISO 13485:2016 and ISO 9001:2015 are far more than administrative necessities - they are the foundation of our promise to customers such as Charité Universitätsmedizin Berlin, Roche and Bayer.
In this article, you will learn what these certifications mean in concrete terms for the safety of your samples and how Consarctic® secures the future of biobanking through certified processes.
EN ISO 13485:2016 is the globally recognized standard for quality management systems in the field of medical devices. For a company in the cryogenics sector, this certification is a clear signal of process reliability and risk minimization.
This standard sets out specific requirements that a company must meet in order to demonstrate its ability to provide medical devices and related services. This includes:
When an IVF center or stem cell bank purchases a Consarctic® freezing device, it buys the certainty that this device has been manufactured according to the same quality standards as life-sustaining medical devices. In a regulated environment (e.g. according to TPG or AMG), this certification is often the basic prerequisite for legally compliant operation.
In addition to the specialist medical standard, Consarctic® is certified in accordance with ISO 9001:2015. While ISO 13485 focuses on product safety, ISO 9001 concentrates on the overall quality of the organization.
ISO 9001 ensures that the requirements and needs of our customers are always understood and met. This is reflected in our range of services - from initial technical advice to long-term maintenance contracts.
At Consarctic®, quality is not an end point, but a spiral. We use feedback from the field to constantly improve our cryo solutions:
A key component of our certified processes is the way in which we hand over a system to our customers. A Consarctic® cryogenic device is never simply "left on the doorstep".
This documents that the appliance has been delivered and installed correctly in accordance with the design requirements. We check all supply connections (e.g. nitrogen lines) and the suitability of the premises.
In this phase, all system functions are tested under real operating conditions. For example, we validate the alarm system and compliance with the preset temperature curves. Only when all tests have been passed do our customers receive the official acceptance certificate, which is essential for conformity in clinical trials or routine operation in accordance with GMP.
Consarctic® systems are designed to support GMP-compliant operation. This means:
It is no coincidence that market leaders such as Roche or prestigious institutions such as the Max Planck Institute rely on Consarctic®. Our certified quality offers them the necessary legal certainty and technical reliability for their groundbreaking research. Whether it is the storage of cancer therapies or the preservation of biological diversity in gene banks - the basis is always a certified process.
Choosing a Consarctic® system means choosing safety at the highest level. Thanks to our dual certification to ISO 13485 and ISO 9001, we guarantee that your samples are optimally protected today, tomorrow and for many years to come.
Would you like to find out more about our high quality standards? Visit our website or contact us directly to gain an insight into our certificates and our "Quality First" cryogenics philosophy.