Podcasts
Medical Devices, Cloud Computing and Cybersecurity with Randy Horton
Published: Nov. 29, 2023, 1:30 p.m.Duration: 27 minutes 56 seconds
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The Business Benefits of Quality
Published: Aug. 11, 2023, 5:17 p.m.Duration: 12 minutes 12 seconds
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The Joy of Document Control
Published: Aug. 9, 2023, 6:13 p.m.Duration: 15 minutes 29 seconds
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Make Quality Make $en$e: Management's Role in Quality
Published: July 31, 2023, 4:43 p.m.Duration: 37 minutes 27 seconds
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MDR By The Numbers: Leveraging New Data for Implementation Planning
Published: March 10, 2023, 4:14 p.m.Duration: 1 hour 18 minutes
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EUDAMED Update: January 2023
Published: Feb. 21, 2023, 5:16 p.m.Duration: 51 minutes 47 seconds
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From the Front Lines of EU Medical Device Regulation
Published: Jan. 31, 2023, 2:53 p.m.Duration: 1 hour 55 seconds
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Risk Management - Beyond the Basics
Published: Dec. 13, 2022, 3:37 p.m.Duration: 54 minutes 31 seconds
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Trends in FDA Initiatives and the Impact on Orthopedic Devices
Published: Nov. 15, 2022, 3:48 p.m.Duration: 38 minutes 14 seconds
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Free FDA Communications with the FDA? What you Need to Know
Published: Nov. 8, 2022, 11 a.m.Duration: 50 minutes 9 seconds
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Split Personalities of QMS Audits for FDA, MDSAP and ISO 13485
Published: Oct. 31, 2022, 2:48 p.m.Duration: 50 minutes 51 seconds
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Usability Testing and the FDA
Published: Oct. 25, 2022, 2:02 p.m.Duration: 32 minutes 35 seconds
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Is your State of Affairs for MDR State of the Art?
Published: Oct. 17, 2022, 2:17 p.m.Duration: 1 hour 3 minutes 11 seconds
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MDR, FDA and Other Regulatory Realities
Published: Sept. 22, 2022, 3:41 p.m.Duration: 35 minutes 41 seconds
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Digital Health: The Future of Medicine and Medical Devices
Published: Sept. 13, 2022, 11:38 a.m.Duration: 43 minutes 14 seconds
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The End of the COVID-Era EUAs
Published: Sept. 6, 2022, 12:03 p.m.Duration: 42 minutes 9 seconds
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Crash Course in FDA Submissions
Published: Aug. 31, 2022, 4:44 p.m.Duration: 25 minutes 10 seconds
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Five Steps to Bring a Medical Device to Market
Published: Aug. 23, 2022, 3:10 p.m.Duration: 29 minutes 22 seconds
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Design Controls and Risk Management
Published: Aug. 17, 2022, 11:31 a.m.Duration: 1 hour 19 minutes 43 seconds
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Breakthrough, de novo, or PMA? FDA Submission Pathways for Novel Devices
Published: Aug. 9, 2022, 1:24 p.m.Duration: 47 minutes 59 seconds
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The Aftermath Of MDR - Part III
Published: Jan. 25, 2022, 6:42 p.m.Duration: 20 minutes 32 seconds
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The Aftermath of MDR - Part II
Published: Jan. 6, 2022, 2:36 p.m.Duration: 15 minutes 23 seconds
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The Aftermath of MDR - Part I
Published: Dec. 16, 2021, 1 p.m.Duration: 15 minutes 40 seconds
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EUDAMED, MDR and Even More Madness with Richard Houlihan
Published: Nov. 23, 2021, 3:37 p.m.Duration: 20 minutes 4 seconds
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EUDAMED, MDR and Other Madness with Richard Houlihan - Part I
Published: Nov. 3, 2021, 11:28 a.m.Duration: 16 minutes 33 seconds
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The MDR No Good Very Bad Day: Go To Market Challenges in the EU
Published: Oct. 15, 2021, 11:31 a.m.Duration: 12 minutes 14 seconds
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The FDA No Good Very Bad Day: Common Regulatory Mistakes
Published: Sept. 29, 2021, 1:03 p.m.Duration: 14 minutes 51 seconds
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Empowering Female Entrepreneurs and Investors with Faz Bashi
Published: July 13, 2021, 11:57 a.m.Duration: 27 minutes 48 seconds
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How A Strong Regulatory Strategy Can Boost Your Business with Stephanie Schull
Published: May 18, 2021, 6 a.m.Duration: 19 minutes 56 seconds
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FDA Submission Pathways with EIT Health Alumni
Published: April 1, 2021, 6 a.m.Duration: 32 minutes 35 seconds
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All You Ever Wanted to Know About Risk Management with Edwin Bills
Published: March 12, 2021, 7 a.m.Duration: 44 minutes 2 seconds
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Regulatory and Reimbursement - Similar but Different
Published: March 4, 2021, 3:16 p.m.Duration: 39 minutes 16 seconds
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FDA Device Downclassification - This is Not Good News
Published: Feb. 25, 2021, 2:13 p.m.Duration: 26 minutes 54 seconds
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Inside a Notified Body with Robert Dostert
Published: Feb. 17, 2021, 7 a.m.Duration: 2 minutes 3 seconds
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Entreprenurial Roundtable with Elena Kyria
Published: Feb. 11, 2021, 1:59 p.m.Duration: 16 minutes 54 seconds
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Entrepreneurial Roundtable with Elena Kyria
Published: Feb. 11, 2021, 1:59 p.m.Duration: 17 minutes 15 seconds
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Ventilators, Components and Accessories - Choosing the Right FDA Pathway for Your Product
Published: Feb. 3, 2021, 7 a.m.Duration: 26 minutes 8 seconds
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Are You Ready for MDR?
Published: Jan. 29, 2021, 7:29 p.m.Duration: 25 minutes 58 seconds
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PPE, Masks and FDA Regulations in the Age of Coronavirus
Published: Jan. 29, 2021, 7:09 p.m.Duration: 12 minutes 51 seconds
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Regulatory Requirements and the "Simple" Surgical Mask
Published: Jan. 22, 2021, 7 a.m.Duration: 11 minutes 27 seconds
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RAQA Today Becomes leanRAQA Today: What's Next?
Published: Jan. 13, 2021, 7 a.m.Duration: 26 minutes 54 seconds
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"Dark Corners" to watch out for in RA/QA-Bryan Brosseau
Published: June 2, 2020, 6:37 p.m.Duration: 30 minutes 39 seconds
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COVID-19 Talent & Recruitment Myths Busted
Published: April 21, 2020, 7:29 p.m.Duration: 23 minutes 16 seconds
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Andy Pal-Associate Dir Software Development-Technician to Leader
Published: April 1, 2020, 5:12 p.m.Duration: 30 minutes 16 seconds
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Bartell & Bartell-Tara Arnold-Shawn Ishler-Driving Peak Performance
Published: Feb. 28, 2020, 5:34 p.m.Duration: 43 minutes
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Molly Tschang-Say it Skillfully Movement
Published: Feb. 21, 2020, 6:06 p.m.Duration: 29 minutes 26 seconds
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Deborah Hiner-Med-Tech Start Up Recruitment Strategies
Published: Nov. 19, 2019, 5:07 p.m.Duration: 22 minutes 15 seconds
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Jess Burger-Elite Escalator Mini Series
Published: Nov. 5, 2019, 4:46 p.m.Duration: 21 minutes 53 seconds
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Monir El Azzouzi
Published: Oct. 9, 2019, 5 p.m.Duration: 18 minutes 40 seconds
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Elias Ketchum-Global RA Director-Genentech-Elite Escalator
Published: Sept. 17, 2019, 4:35 p.m.Duration: 23 minutes 59 seconds
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RAQA - Michelle Lott-Lean RA QA-Private Equity in the Life Sciences
Published: Sept. 4, 2019, 12:06 a.m.Duration: 19 minutes 5 seconds
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Jon Speer-Greenlight Guru-True Quality
Published: Aug. 15, 2019, 9:10 p.m.Duration: 25 minutes 16 seconds
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RAQA - Mark Mannebach-Former VP RA/QA Charleston Laboratories
Published: May 21, 2019, 8:15 p.m.Duration: 43 minutes 43 seconds
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RAQA Diane Renz-The Power of Mindfulness
Published: April 23, 2019, 4:03 p.m.Duration: 37 minutes 21 seconds
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RAQA - Jose Zayas-VP RAQA-Making the leap into Consulting
Published: April 2, 2019, 4:42 p.m.Duration: 30 minutes 1 second
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RAQA - Gowri Sukumar-Setting API Specifications
Published: March 5, 2019, 10:04 p.m.Duration: 7 minutes 58 seconds
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RAQA - Mitch Robbins-Adam Saupe-Interview Prep
Published: Feb. 21, 2019, 10:37 p.m.Duration: 19 minutes 56 seconds
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RAQA - Tracy Burns-CEO-NEHRA-CHRO Development Program
Published: Feb. 19, 2019, 2:08 p.m.Duration: 27 minutes 6 seconds
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RAQA - Divya Ghatak-VP People-Nevro-Dealing with Rapid Change
Published: Feb. 6, 2019, 4:46 p.m.Duration: 25 minutes 5 seconds
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RAQA - Stephen Amato-Faculty Director-Notheastern University
Published: Feb. 5, 2019, 5:28 p.m.Duration: 17 minutes 44 seconds
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RAQA - Rashida Najmi-SVP Global Regulatory, Quality & Pharmacovigilance
Published: Jan. 22, 2019, 5:19 p.m.Duration: 30 minutes 53 seconds
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RAQA - Brian Ellis-Talent Attraction Mgr-Align Technology-Talent Branding
Published: Jan. 16, 2019, 5:49 p.m.Duration: 33 minutes 58 seconds
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RAQA - Rob Packard-Global Impact-EU MDR-IVDR Changes
Published: Jan. 8, 2019, 8 p.m.Duration: 24 minutes 36 seconds
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RAQA - Liz Ashraf-VP Reg Affairs-MaxiNovel-Advil
Published: Dec. 11, 2018, 9 p.m.Duration: 24 minutes 51 seconds
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RAQA Mira Leiwant-VP Reg Affairs-BTG plc
Published: Dec. 4, 2018, 9:51 p.m.Duration: 32 minutes 37 seconds
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RAQA - David Kern-K2 Regulatory-Biggest Misconception in Regulatory
Published: Nov. 27, 2018, 8:34 p.m.Duration: 42 minutes 27 seconds
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RAQA - Darshan Kulkarni-Transparency in the Life Sciences
Published: Nov. 13, 2018, 7 p.m.Duration: 19 minutes 29 seconds
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RAQA - Dr Joy Frestedt-EU MDR Are You Prepared?
Published: Nov. 8, 2018, 12:03 a.m.Duration: 34 minutes 42 seconds
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RAQA - Shandon Hayes-Global Talent Acquisition-Natus Medical
Published: Oct. 30, 2018, 3:45 p.m.Duration: 27 minutes 18 seconds
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RAQA - Ghazi Kashmolah-SVP RA/QA DJO Global
Published: Oct. 30, 2018, 3 p.m.Duration: 36 minutes 14 seconds
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RAQA - Janielle Newland - Head Of People & Culture - Genevant Sciences
Published: Oct. 23, 2018, 6:40 p.m.Duration: 18 minutes 2 seconds
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RAQA - Urte Gayko-Head of Global Reg Affairs & PMO-Pharmacyclics
Published: Oct. 18, 2018, 6:58 p.m.Duration: 49 minutes 25 seconds
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RAQA - Evan Rosenfeld - Founder MDJD Consulting
Published: Oct. 16, 2018, 6 p.m.Duration: 42 minutes 22 seconds
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RAQA - Eric Richards-VP-Head of Regulatory Affairs-Oncology-Daiichi Sankyo
Published: Oct. 11, 2018, 6:31 p.m.Duration: 41 minutes 24 seconds
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RAQA - Karen Anderson-CHRO-Alnylam Pharmaceuticals
Published: Oct. 9, 2018, 6 p.m.Duration: 41 minutes 38 seconds
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RAQA - Lisa DiMolfetto-VP Regulatory Affairs-Science 37
Published: Oct. 4, 2018, 9:05 p.m.Duration: 54 minutes 4 seconds
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RAQA - Lisa Mathis-VP Regulatory Affairs/R&D-Amgen
Published: Oct. 2, 2018, 6 p.m.Duration: 38 minutes 2 seconds
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RAQA - Stefan Ochalski VP Regulatory Affairs-Taiho Oncology
Published: Sept. 27, 2018, 6 p.m.Duration: 38 minutes 27 seconds
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Gary Charbonneau-SVP Regulatory Affairs-Sarepta Therapeutics
Published: Sept. 25, 2018, 6 p.m.Duration: 26 minutes 33 seconds
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RAQA - Elliott Berger-SVP Regulatory Affairs-BioCryst
Published: Sept. 20, 2018, 6 p.m.Duration: 41 minutes 30 seconds
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Rob Cormack-Regulatory Affairs Consultant
Published: Sept. 18, 2018, 5:25 p.m.Duration: 15 minutes 34 seconds
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