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#66 Navigating the Impact of EU MDR and Clinical Evidence with Ethan Drower: Post Market Surveillance, State of the Art and Continuous Monitoring
Ethan Drower Co-Founder and CEO at Cite Medical brings a unique blend of expertise to the table. His background as a trained software engineer, coupled with his partner's veteran experience in regulatory affairs and quality makes him an expert in the clinical space
In this episode, we discuss the impact of EU MDR on medical device manufacturers, the changes in clinical evidence requirements, the concept of state of the art alongside what this means in practice in addition to the need for adequately qualified reviewers and the challenges faced by smaller startups in finding the required expertise
Timestamps:
[00:02:36] Importance of literature review in research
[00:15:30] Continuous monitoring critical for device safety
[00:19:21] Regulatory and clinical synergy in business
[00:21:26] Clinical data and evaluation are crucial.
[00:24:56] Passionate about travel and cultural experiences.
[00:28:05] Sailor and motorcycle enthusiast, open to travel anywhere. Advice: improve regulatory skills, not fight against regulations.
Get in touch with Ethan Drower - https://www.linkedin.com/in/ethandrower/
Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/
Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal
Subscribe to the Podcast
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By Karandeep Singh Badwal
5
77 ratings
Ethan Drower Co-Founder and CEO at Cite Medical brings a unique blend of expertise to the table. His background as a trained software engineer, coupled with his partner's veteran experience in regulatory affairs and quality makes him an expert in the clinical space
In this episode, we discuss the impact of EU MDR on medical device manufacturers, the changes in clinical evidence requirements, the concept of state of the art alongside what this means in practice in addition to the need for adequately qualified reviewers and the challenges faced by smaller startups in finding the required expertise
Timestamps:
[00:02:36] Importance of literature review in research
[00:15:30] Continuous monitoring critical for device safety
[00:19:21] Regulatory and clinical synergy in business
[00:21:26] Clinical data and evaluation are crucial.
[00:24:56] Passionate about travel and cultural experiences.
[00:28:05] Sailor and motorcycle enthusiast, open to travel anywhere. Advice: improve regulatory skills, not fight against regulations.
Get in touch with Ethan Drower - https://www.linkedin.com/in/ethandrower/
Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/
Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal
Subscribe to the Podcast
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