DiscoverDigital Health Section Podcast- Royal Society of MedicineRegulation: Tips from ex-MHRA & FDA regulators. With Johan Ordish ex-MHRA and Brendan O'Leary ex-FDA
Regulation: Tips from ex-MHRA & FDA regulators. With Johan Ordish ex-MHRA and Brendan O'Leary ex-FDA

Regulation: Tips from ex-MHRA & FDA regulators. With Johan Ordish ex-MHRA and Brendan O'Leary ex-FDA

Update: 2024-07-14
Share

Description

This episode explores software as a medical device regulation on both sides of the Atlantic.  It features two incredible guests, Johan (ex-MHRA) and Brendan (ex-FDA) who share their unique perspectives from their respective experience at regulatory agencies.

Discussion points include:

The key differences between the EU, UK and US approaches to regulation
- How these differences impact market entry strategy
- Approaches to regulating AI including the EU AI Act and what it means for AI medical device manufacturers
- International regulatory harmonization efforts - Key Dos and Don’ts when interacting with regulators



Comments 
loading
Top Podcasts
The Best New Comedy Podcast Right Now – June 2024The Best News Podcast Right Now – June 2024The Best New Business Podcast Right Now – June 2024The Best New Sports Podcast Right Now – June 2024The Best New True Crime Podcast Right Now – June 2024The Best New Joe Rogan Experience Podcast Right Now – June 20The Best New Dan Bongino Show Podcast Right Now – June 20The Best New Mark Levin Podcast – June 2024
In Channel
AI in Ophthalmology. With Prof Pearse Keane- Consultant Ophthalmologist at Moorfields and Professor of Artificial Medical Intelligence at University College London

AI in Ophthalmology. With Prof Pearse Keane- Consultant Ophthalmologist at Moorfields and Professor of Artificial Medical Intelligence at University College London

2024-11-1135:45

Scaling AI in the NHS: Lessons from the stroke AI rollout. With Darrien Bold- NHS England & Dr George Harston- CMIO, Brainomix

Scaling AI in the NHS: Lessons from the stroke AI rollout. With Darrien Bold- NHS England & Dr George Harston- CMIO, Brainomix

2024-10-2735:20

MedLM: Google's medical foundation models. With Dr Dillon Obika- Senior Clinical Specialist at Google

MedLM: Google's medical foundation models. With Dr Dillon Obika- Senior Clinical Specialist at Google

2024-10-1439:22

AI Implementation Insights from the Health Foundation. With Malte Gerhold- Director of Innovation and Improvement

AI Implementation Insights from the Health Foundation. With Malte Gerhold- Director of Innovation and Improvement

2024-09-2337:07

AI in Radiology. With Dr Kath Halliday- President of the Royal College of Radiologists

AI in Radiology. With Dr Kath Halliday- President of the Royal College of Radiologists

2024-09-0233:14

Explaining Explainable AI (Dev & Doc Special). With Dr Josh Au Yeung and Zeljko Kraljevic- Hosts of the Dev & Doc Podcast

Explaining Explainable AI (Dev & Doc Special). With Dr Josh Au Yeung and Zeljko Kraljevic- Hosts of the Dev & Doc Podcast

2024-08-1555:08

Validating Digital Health Technologies. With Professor David Lowe- Clinical Director for Innovation at the Digital Health Validation Lab, University of Glasgow

Validating Digital Health Technologies. With Professor David Lowe- Clinical Director for Innovation at the Digital Health Validation Lab, University of Glasgow

2024-07-2936:17

Regulation: Tips from ex-MHRA & FDA regulators. With Johan Ordish ex-MHRA and Brendan O'Leary ex-FDA

Regulation: Tips from ex-MHRA & FDA regulators. With Johan Ordish ex-MHRA and Brendan O'Leary ex-FDA

2024-07-1440:58

111 & Digitising the NHS front door. With Dr James Ray- National Clinical Advisor for Urgent and Emergency care at NHS England

111 & Digitising the NHS front door. With Dr James Ray- National Clinical Advisor for Urgent and Emergency care at NHS England

2024-07-0129:57

AI & the Limits of Clinician Vigilance. With Prof Julia Adler-Milstein- Professor at University of California

AI & the Limits of Clinician Vigilance. With Prof Julia Adler-Milstein- Professor at University of California

2024-06-1725:21

Healthtech market trends and trajectory. With Dr Molly Gilmartin- Health Tech Investor at AlbionVC

Healthtech market trends and trajectory. With Dr Molly Gilmartin- Health Tech Investor at AlbionVC

2024-05-2030:04

Investment in Healthcare. With Dr John Lee Allen – Managing Partner at RYSE Asset Management

Investment in Healthcare. With Dr John Lee Allen – Managing Partner at RYSE Asset Management

2024-05-0632:27

The Ethical Implications of Digital Transformation. With Jess Morley- Health Data Academic at Yale Digital Ethics Centre

The Ethical Implications of Digital Transformation. With Jess Morley- Health Data Academic at Yale Digital Ethics Centre

2024-04-2240:58

Bias in Healthcare AI. With Dr Xiao Liu- Senior Clinician Scientist in AI & Digital Health, University Hospitals Birmingham NHS Foundation Trust

Bias in Healthcare AI. With Dr Xiao Liu- Senior Clinician Scientist in AI & Digital Health, University Hospitals Birmingham NHS Foundation Trust

2024-04-0832:39

Post-market Surveillance of AI medical devices. With Dr Dan Mullarkey- Medical Director at Skin Analytics

Post-market Surveillance of AI medical devices. With Dr Dan Mullarkey- Medical Director at Skin Analytics

2024-03-1934:35

Clinical Copilots. With Dr Dom Pimenta- CEO of Tortus

Clinical Copilots. With Dr Dom Pimenta- CEO of Tortus

2024-02-2647:55

What's holding back AI in healthcare? With Dr Chris Kelly- Clinical Research Scientist at Google

What's holding back AI in healthcare? With Dr Chris Kelly- Clinical Research Scientist at Google

2024-02-1137:24

Intellectual property for Healthtech & AI. With Stephen Carter- Patent Attorney and IP consultant

Intellectual property for Healthtech & AI. With Stephen Carter- Patent Attorney and IP consultant

2024-01-2943:54

Building an AI-ready NHS. With Haris Shuaib- Head of Clinical Scientific Computing at Guy's and St Thomas'​ NHS Foundation Trust

Building an AI-ready NHS. With Haris Shuaib- Head of Clinical Scientific Computing at Guy's and St Thomas'​ NHS Foundation Trust

2024-01-1634:42

Pitching healthtech to the NHS. With Sara Nelson- DigitalHealth.London Programme Director

Pitching healthtech to the NHS. With Sara Nelson- DigitalHealth.London Programme Director

2023-12-1825:26

loading
Google Play
Download from Google Play
Castbox
Download from App Store
usUnited States
00:00
00:00
1.0x

0.5x

0.8x

1.0x

1.25x

1.5x

2.0x

3.0x

Sleep Timer

Off

End of Episode

5 Minutes

10 Minutes

15 Minutes

30 Minutes

45 Minutes

60 Minutes

120 Minutes

Regulation: Tips from ex-MHRA & FDA regulators. With Johan Ordish ex-MHRA and Brendan O'Leary ex-FDA

Regulation: Tips from ex-MHRA & FDA regulators. With Johan Ordish ex-MHRA and Brendan O'Leary ex-FDA

RSM Digital Health Council