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Regulatory Affairs, Medical Devices
Medical Device

Regulatory challenges for Software ​​​​​as Medical Device (SaMD) and AI

Posted by on 24 February 2020
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Software as Medical Device (SaMD) and Artificial Intelligence are the future of MedTech, yet they both bring their own set of regulatory challenges. We asked six industry experts for their views on the regultory challenges and impact SaMD and AI will have on the medical device landscape - read their full responses in the interactive eBook below (or click here):

The questions we asked included:.

  • What are the biggest regulatory challenges for SaMD at the moment?
  • What impact will software and AI have on the regulatory landscape for medical devices?
  • What are the common mistakes companies are making with regulating their SaMD?
  • Are regulatory bodies ready to regulate SaMD and AI? If not, why not?
  • How will SaMD and AI impact patients? Is this considered enough during reimbursement?

The industry insiders we spoke are:

  • Mona Dean, Senior Consultant In Vitro Diagnostics & Quality, Precision for Medicine
  • Jo-Ann Gonzales, Director In Vitro Diagnostics & Quality, Precision for Medicine
  • Petra Hoogendoorn, Researcher, National eHealth Living Lab, and startup founder
  • Nele Ooms, QA Manager, UgenTec
  • Johan Ordish, Senior Policy Analyst (Law and Regulation), PHG Foundation
  • Tobias Schreiegg, Director Regulatory Affairs, Siemens Healthineers
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