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Funded project.

Intelligent post-market surveillance software for medical device manufacturers

inotec Forschungs- und Entwicklungsgesellschaft mbH is launching an intelligent post-market surveillance software for medical device manufacturers.

Market launch of an intelligent post-market surveillance software

Beneficiary
inotec Forschungs- und Entwicklungsgesellschaft mbH
Project
inotec Forschungs- und Entwicklungsgesellschaft mbH is launching an intelligent post-market surveillance software for medical device manufacturers.
Objective
Small and medium-sized medical technology companies must systematically monitor their products after placing them on the market and meet the requirements of the MDR and the standards DIN EN ISO 13485 and DIN EN ISO 14971, but often have only limited staff resources for this. The project aims to give these companies access to an audit-ready, structured and SME-appropriate solution and to develop the market preparation required for it.
Funding
The project is funded under the funding guideline “Markteinführung Zuschuss EFRE 2021 bis 2027” (market launch grant, ERDF 2021–2027).
Logo of the European Union: Co-funded by the European Union
Coat of arms of the Free State of Saxony: This measure is co-financed with tax revenue on the basis of the budget adopted by the Saxon State Parliament.

Further project

AI-supported QM software as SaaS

Market launch of Dyrk, an AI-supported software for quality management and regulatory risk management – for managing regulatory requirements under the MDR and DIN EN ISO 13485, as SaaS.

Co-funded by the European Union.

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