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Hi Nick! Thanks for the invite to this group. My background is in Quality Engineering and QMS setup/ISO 13485. I’m working on building a consulting practice but at the moment am also open to fractional/contract positions. Wondering if you could help me best position myself for that kind of work or if you know of any opportunities. Thanks!

Thank you! The general consensus seems that its incredibly de-regulating. Normally I think we would all applause at that but it may sway into a potentially dangerous zone. Will be interesting to see how some key players respond next.

For anyone working with wellness or borderline wellness devices, what’s your next step? I have one so now I…

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There have been some good insights on LinkedIn. One of the issues I have is that they didn’t get public comment! https://www.linkedin.com/posts/mjasonbrooke_general-wellness-policy-for-low-risk-devices-activity-7414359212451102722-9PLY?utm_source=share&utm_medium=member_desktop&rcm=ACoAAAY0NpUBd5pZbxu-B62mmGtViLpjTk8RI30

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General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff | M. Jason Brooke | 11 comments

The FDA has--without public comment--updated the #ClinicalDecisionSupport Guidance and the #GeneralWellness Guidance. The #FDA appears to have taken a de-regulatory approach, expanding the scope of what falls into the non-device category of products. Below are links to each of the … Continue reading