Plasmaconcept not only distributes medical devices, but also manufactures the innovative IMPACT Platform for Autologous Cell Therapies — a highly advanced centrifuge designed to produce a range of autologous cell therapies.
IMPACT is distributed directly by Plasmaconcept in Germany, while IMPACT International GmbH handles international distribution to global partners.
INNOVATIVE TECHNOLOGY
IMPACT: Made in Germany — successful worldwide!
Plasmaconcept has been the successful manufacturer of the IMPACT Platform for Autologous Cell Therapies and its accessories since its launch in 2018. Plasmaconcept benefits from many years of experience in distributing medical devices and has close connections within the field of orthopaedics.
We are proud to be one of the first medical device manufacturers in Europe to have successfully completed the approval process under the new European Union Medical Device Regulation (EU MDR 2017/745) for all our products. This makes IMPACT one of the first MDR-certified products for autologous cell therapies, ensuring compliance with the highest current European standards for quality and safety in medical devices.
The early MDR certification highlights Plasmaconcept’s commitment to high-quality standards and product safety. This includes our certification as a medical device manufacturer according to ISO 13485. We apply strict criteria when selecting our service providers and suppliers, maintaining long-standing and trusted partnerships. Wherever possible, also in terms of sustainability, we rely on production in Germany or Europe. For example, our IMPACT centrifuge is manufactured entirely in Germany.
Further information on the international distribution of the IMPACT centrifuge is available at: www.impactinternational.de.
