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

Regulatory challenges for Software as Medical Device (SaMD) and AIInsights from six industry insiders (Feb 2020)Six MedTech industry insiders explore the regulatory challenges for Software as Medical Device (SaMD) and AIContents

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

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 following questions.

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?

Scroll on to explore all their responses.

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Industry Insiders

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