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Jun 30, 2022

aprimeo diagnostics Receives the ISO 13485 Certificate

Pfungstadt, 30.06.2022 – It was a journey. Now, we are pleased to announce that aprimeo diagnostics has been certified according to ISO 13485, since the end of June. This ISO standard specifies requirements for a comprehensive quality management system for the development, the manufacturing and market placement of medical devices.

We took this step of externally auditing of our quality management system to be able to offer customers, users and patients the greatest possible safety, reliability and excellent service. Regular monitoring of our internal processes and compliance with legal requirements ensures that aprimeo diagnostics always works in accordance with current regulations, that workflows are carried out with consistent quality and that processes are continuously optimised.

With the certification, we have reached another milestone and are proud to be able to present this internationally recognised proof of competence, quality and performance.

Mdc Plakette ISO13485 e

About aprimeo diagnostics

aprimeo diagnostics GmbH & Co. KG is a R‑Biopharm AG company, focused on the distribution of innovative, next-level diagnostic solutions. R‑Biopharm´s partnership with Bosch Healthcare Solutions enables aprimeo diagnostics to provide the innovative molecular diagnostic platform Vivalytic to healthcare professionals, making it possible for them to take better decisions on therapy for their patients each and every day.

Media contact

aprimeo diagnostics GmbH & Co. KG

Frank Apostel, Ph.D.
Managing Director & Partner
Phone: +49 (0)6151 800238 – 50
E‑Mail: email hidden; JavaScript is required

Bosch Healthcare Solutions GmbH

Thomas Berroth
Marketing & Communication
Phone: +49 (0) 711 811 – 45599
E‑Mail: email hidden; JavaScript is required

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