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Blending Agile Practices With Industry Regulations: An In-Depth Q&A Webinar Banner
Blending Agile Practices With Industry Regulations: An In-Depth Q&A Webinar
It may be hard to believe, but it’s been 10 years since AAMI published TIR:45 2012, Guidance On The Use Of AGILE Practices In The Development Of Medical Device Software. Orthogonal is hosting a series of events and conversations to mark the occasion, aimed at sharing cutting-edge insights that will collectively help us move faster and break nothing in SaMD development.

Last month, we hosted a webinar with two highly successful practitioners of Agile SaMD: Michael Iglesias and Larkin Lowrey. You can read the summary of what they discussed, as well as watch the full video here. Our guests reflected on how Agile has transformed – and will continue to transform – the MedTech industry. With so much to say, they didn’t have time to dive into many of the great (and detailed) questions that came in from our audience.

To give our experts the time to address these great questions, we’re holding a follow-up webinar where Michael and Larkin will go into the nitty-gritty details on blending Agile practices with QMS, IEC 62304 and ISO 13485 at a tactical level. Join us on July 28 from 1-1:45 PM EDT for this in-depth and highly informative session with two guests who have held roles at Roche, J&J, Eli Lilly, Novo Nordisk, Philips and Tandem Diabetes Care, as well as in automotive and telecommunications critical infrastructure – close cousins to MedTech.

Michael and Larkin will answer our audience’s detailed questions with practical advice and tactical steps to take to achieve Agile SaMD success. You’ll learn how you can take the best of Agile and the true intent of industry regulations and combine them in a way to raise the bar on the safety, quality and effectiveness of medical devices.


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Michael Iglesias
Global Advisor on Digital Health Quality & Compliance @Roche
Michael Iglesias, who has worked on SaMD at a number of world-class MedTech firms (J&J, Eli Lilly, Novo Nordisk, and Philips) before joining Roche as a Global Advisor on Digital Health Quality & Compliance. Prior to working in SaMD, Michael was on the team at Apple developing the very first iPhone.
Larkin Lowrey
Senior Director for Software Engineering. (most recent role) @Tandem Diabetes Care (Most recent role)
Larkin Lowrey, who most recently worked at Tandem Diabetes Care as a Senior Director for Software Engineering. He implements Agile best practices learned over 20+ years from building high-performance software engineering teams and products for two other critical infrastructure industries: telecommunications and automotive.