Plasmaconcept not only distributes medical devices but is also the manufacturer of the innovative IMPACT Platform for Autologous Cell Therapies — a highly advanced centrifuge designed to produce a range of autologous cell therapies.
In Germany, IMPACT is distributed directly by Plasmaconcept, while international distribution to global partners is handled by IMPACT International GmbH.
INNOVATIVE TECHNOLOGY
IMPACT: made in Germany – successful worldwide
For several years, Plasmaconcept has been successfully active as the manufacturer of the IMPACT Platform for Autologous Cell Therapies and its accessories, which was launched in 2018. In doing so, Plasmaconcept benefits from its many years of experience in the distribution of medical devices and its close connections within the field of orthopedics.
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 products we manufacture. This makes IMPACT one of the first MDR-certified products for autologous cell therapies and ensures compliance with the highest current European standards for quality and safety in medical devices.
This early MDR certification highlights Plasmaconcept’s commitment to high-quality standards and product safety. This also 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. Whenever possible – also in terms of sustainability – we rely on production in Germany or Europe. For example, our IMPACT centrifuge is entirely manufactured in Germany.
For more information about international distribution of: www.impactinternational.de.
