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Let's talk global medical device + IVD regulatory services - deep links to episodes

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Just want to link to the podcast? Use this magic link: Listen to Let's talk global medical device + IVD regulatory services

Jun 16 2020:Let's talk clinical evidence reports - what you need to know.
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May 20 2020:Faster Australian Medicine Approvals through Leveraging International Evaluations
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Apr 9 2020:Emergency approvals - moving things along in a Pandemic
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Mar 18 2020:Biocompatibility - Chemistry takes over from biology and cell cultures replace laboratory animals
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Feb 19 2020:Nobody Complained! Post market reporting under MDR.
Apple Podcasts | Google Podcasts | Audio file
Jan 22 2020:Harmonization - the Triumphs and the Tragedies
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Nov 21 2019:The Case For Quality
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Oct 24 2019:Shouldn't diagnostics be different to Medical Devices? Understanding the changes to diagnostics in Europe with the IVDR.
Apple Podcasts | Google Podcasts | Audio file
Sep 27 2019:When Software becomes a Medical Device (SaMD)
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Jun 20 2019:Time to get serious on postmarket
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May 22 2019:Documentation Deconstructed: Understanding the Technical file
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Apr 24 2019:How to survive the Perfect Storm - International Harmonization and Lessons from Brexit and the MDR
Apple Podcasts | Google Podcasts | Audio file
Mar 21 2019:A Bulletproof Clinical Evaluation Report: Making them stand up to regulatory scrutiny
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Feb 22 2019:Biocompatibility Challenges for 2019
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Jan 29 2019:Making American Guidance Understandable Again: How FDA's new enthusiasm for harmonization brings opportunity for international firms.
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Dec 16 2018:FDA and ISO stars aligning on ISO 10993
Apple Podcasts | Google Podcasts | Audio file
Dec 13 2018:Taking a 510(k) Down Under...leveraging US (and Canadian and Japanese) approvals for TGA registration
Apple Podcasts | Google Podcasts | Audio file

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