
 In this episode, Shannon Hoste at Agilis Consulting Group and Duane Mancini discuss her background in Medtech, human factors testing for software as medical device, cognitive systems engineering, IEC 62366 and the FDA guidance document on human factors, and so much more.
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  Agilis Consulting Group Website
  Project Medtech Website
  Project Medtech LinkedIn
  Duane Mancini LinkedIn


Episode 142 | Shannon Hoste, President at Agilis Consulting Group | Human Factors for Digital Health and SaMD

The Project Medtech podcast is interview-style podcast on the Medtech Industry where guests share stories, advice, pitfalls, trends and innovations produced by Project Medtech.

Science

Life Sciences

In this episode, Andrew Fish and Joseph Sapiente at Medical Device Innovation Consortium (MDIC) and Duane Mancini discuss the mission of MDIC, the various initiatives and programs, how to engage MDIC and so much more.

Episode 182 | Andy Fish, CEO & President and Joe Sapiente, Senior Vice President at Medical Device Innovation Consortium (MDIC) | Facilitating Discussions between Government and Industry

In this episode, Brittani Ritchie at Project Medtech and Duane Mancini discuss her background in the Medtech industry, making quality a part of your culture, what to expect in an FDA audit and so much more.

Episode 181 | Brittani Ritchie, Consultant, Operations at Project Medtech | Making Quality a Part of Company Culture

In this episode, Charles Allan at MY01 and Duane Mancini discuss his background in the Medtech industry, what MY01 is working on, the Medtech Innovator program, focus on collecting clinical data for commercialization support, fundraising strategies as you advance rounds, the Canadian Medtech ecosystem and so much more.

Episode 180 | Charles Allan, Chief Executive Officer at MY01 | Lessons Learned So Far from a Medtech Startup CEO

In this episode, Michelle Lott at LeanRAQA and Duane Mancini discuss the QMSR, FDA e-start program, 513g vs. presubmission meeting, MDR update and so much more.

Episode 179 | Michelle Lott, Principal and Founder at LeanRAQA | FDA and MDR Updates

In this episode, Kevin Saem at Zapyrus and Duane Mancini discuss what Zapyrus does, their 2023 Medtech report on the industry and so much more.

Episode 142 | Shannon Hoste, President at Agilis Consulting Group | Human Factors for Digital Health and SaMD

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