Founded in 2014, Platomics GmbH is a Vienna-based company that builds software to automate regulatory compliance in the in vitro diagnostics (IVD) industry. Its core offering, the PlatoX® platform, digitalizes regulatory workflows required under the EU's In Vitro Diagnostic Regulation (IVDR), aiming to reduce the time and cost associated with bringing diagnostic products to market.
The company's technical work spans regulatory compliance automation, bio-informatics, data digitalization, and quality management systems. Platomics serves IVD manufacturers, laboratories, and pharmaceutical companies, with particular relevance to healthcare diagnostics in areas such as rare diseases and oncology. The firm has held ISO 13485 certification for its quality management system since 2018 and operates on ISO 27001-certified data center infrastructure.
Platomics employs a multidisciplinary team of regulatory experts, bio-informaticians, software engineers, and medical professionals drawn from 29 countries. The company's European operations are headquartered in Vienna.
