CertHub GmbH

CertHub eases the regulatory challenges of medical device manufacturers by automating compliance tasks through an All-in-One AI software that streamlines QMS and technical documentation processes to bring products to market years faster.

 

CertHub GmbH is an innovative company based in Munich that offers AI-supported software solutions tailored to the needs of the healthcare sector. We support medical technology and pharmaceutical companies, that suffer from regulatory and documentation overload, to bring their products to the market and patients faster, easier and more cost-effectively. Our solution is developed by a team of industry experts who have first-hand experience of the effort and difficulties associated with the new regulations. From the industry, for the industry.

**Products / Offer / Service**
– AI-supported compliance software for the automation of approval, documentation and quality processes tailored to the needs of medical device manufacturers
– All-in-one platform for digital technical documentation and quality management system tailoring to the specific medical devices
– Expert advice on digital transformation, use of artificial intelligence in regulated industries and process optimization

With our digital quality management system, processes come to life: the right colleagues are notified if necessary and verification documents are automatically created, which can be approved within the platform using e-signatures to include the latest content in the technical documentation compliant with EU MDR as well as FDA.

Thanks to our novel data-driven solution, product information needs to be maintained only once (no redundant documents and content anymore), from which the required documents and reports are created automatically exactly in the required format and structure – Technical Documentation with the press of a button!

With CertHub, more than 60% of the time and manual effort in quality management and regulatory affairs can be saved through our AI powered software platform, allowing medical device manufacturers to bring products to market years faster (risk class I, IIa, IIb, III), reduce the high workload on QM and RA experts and ensure continuous compliance of their products.

Your Contact Person(s)

CertHub GmbH

Tal 44

80331 München

 

Leon Kobinger (CEO)

E-Mail: leon.kobinger@certhub.de

 

Jonas Bayer (COO)

E-Mail: jonas.bayer@certhub.de

Phone: +49 155 60603698

 

Nicolas Gehring (CTO)

E-Mail: nicolas.gehring@certhub.de

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