MedSysCon Medizintechnik GmbH

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1-10 employees

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MedSysCon Medizintechnik GmbHposted an update•28 February

https://www.medsyscon.com/en/blog-lisci/

Top ten observations from 2022 in life sciences digital and analytics - MedSysCon Medizintechnik GmbH

Life sciences companies are making progress in adopting and deploying digital and analytics. But they can go further and faster by heeding some lessons from the past few years. Looking toward the new year is a good time ...www.medsyscon.com

MedSysCon Medizintechnik GmbHposted an update•28 February

https://www.medsyscon.com/en/blog-ivd-samd/

The FDA & EU IVDR Regulatory Frameworks For IVD SaMD - MedSysCon Medizintechnik GmbH

Software that is qualified as an in vitro diagnostic medical device (known as SaMD IVD) is affected by the same requirements as other medical devices, which are governed by various FDA regulations and EU In Vitro Diagnostic (IVD) Regulation EU 2017/746. Therefore, ...www.medsyscon.com

MedSysCon Medizintechnik GmbHposted an update•28 February

https://www.medsyscon.com/en/blog-gpt/

GPT Applications in Healthcare? - MedSysCon Medizintechnik GmbH

Natural language computer applications are becoming increasingly sophisticated and, with the recent release of Generative Pre-trained Transformer 3, they could be deployed in healthcare-related contexts that have historically comprised ...www.medsyscon.com

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About us

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With employees & partners having 20+ years of experience, we are offering consulting and support in the following areas within Medtech: • Quality Management, including audits according to ISO 13485: 2016 • Risk Management according to ISO 14971 • Regulatory Affairs • Medical Device Regulation (MDR) • Software As a Medical...