In this episode, Michelle chats with SexTech compliance specialist and consultant, Heather Carre-Skinner. They talk about the compliance and regulatory needs in the SexTech industry, sex toy body safety, and many other regulatory and complaince concerns.
Check out Heather’s Bio:
“I started off my career as a scientist with a PhD in molecular biology from the Royal Veterinary College, and then after a couple of post-docs I decided to hang up my lab coat and move into the world of medical device Quality Assurance and Regulatory Affairs.
I have held senior roles in both start-up and established biotech companies and successfully implemented and maintained ISO 13485, ISO 27001 and ISO 9001, as well as working to standards IEC 62304, IEC 62366 and ISO 14971. I also produced technical file writing and CE marking submissions under the IVDD, IVDR and MDR.
In mid 2022 I took the leap and started my own medtech consultancy company. My aim is to help new, small and SME to understand quality processes, implement them in a way that brings success to the company and most importantly get your product to the market.
I have a keen interest in novel innovation, software as medical devices, femtech and sextech and would love to work with those that want to get safe products out there for all.”
Some topics Michelle and Heather discuss in this episode:
Sex toys as medical devices
Sex toy safety certification
ISO 3533 regulatroy standard
The biggest concers with sex toy safety
There is no formal safety mark for sex toys
Data privacy in SexTech
Sex toy risk assessment
What to look for when you buy a sex toy
Problems with sex toys on the market
Article by Heather:
Podcast music:
antidepresseur by Patchworker f.k.a. [friendzoned] | https://soundcloud.com/patchworker
Music promoted by https://www.free-stock-music.com
Creative Commons Attribution-ShareAlike 3.0 Unported
Edited with PodCastle.ai
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