MedSysCon Medizintechnik GmbH
The FDA & EU IVDR Regulatory Frameworks For IVD SaMD - MedSysCon Medizintechnik GmbHSoftware 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
GPT Applications in Healthcare? - MedSysCon Medizintechnik GmbHNatural 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
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...