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Regulatory Pathway: How to reach the US market? [510k exempt]
If you are willing to reach out to the US there may be multiple strategies. We will talk today about MysteryVibe that started to evaluate the market and identified that their product is class IIa in EU and Class II in the US. But in the US this is 510k exempt so let's here their journey. The post Regulatory Pathway: How to reach the US market? [510k exempt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
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Show Notes
You maybe ask yourself how to get to distribute your Medical Device in the US? Then listen to the story of MysteryVibe with their devices. He will answer questions such as: – Why the US market and not the EU? – What was the interaction with consultants for the Quality and Regulatory aspects? – How is it to work with a Quality Management System? – How is the logistic of the product working? – Why perform Clinical Investigations? So I hope this will help you understand the market by listening to the MysteryVibe Journey.
Who is Dr.Soumyadip Rakshit?
Dr. Soum Rakshit is the Co-Founder & CEO of the award-winning sexual health company, MysteryVibe. Their mission is to make sexual health accessible to all – across all ages, genders & orientations. In his role as CEO of MysteryVibe, he focuses on pushing the boundaries on R&D, and customer experience and supporting their long-term goal of making sexual health an integral part of our overall health. Soumyadip passionately believes that by empowering people with actionable knowledge & purposeful innovation is the way to make this happen. Soumyadip built and sold his first startup in defense electronics by age 26, and has won 20+ International design awards for his product designs.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links
- Dr. Soumyadip Rakshit Linkedin: https://www.linkedin.com/in/soum
- Mysteryvibe website: https://mysteryvibe.com/
- Literature on disease targeted: https://eventclass.org/contxt_essm2022/scientific/online-program/session?s=P-07#e524
- MysteryVibe LinkedIn Page: https://www.linkedin.com/company/mysteryvibe/
- Easy Medical Device Authorized Representative: https://easymedicaldevice.com/authorised-representative-and-importer/
The post Regulatory Pathway: How to reach the US market? [510k exempt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi