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QMS Best Practices for SaMD and Devices Featuring Software
QMS Best Practices for SaMD and Devices Featuring Software
This microlearning course is designed to equip you with essential knowledge and best practices for successfully implementing a QMS tailored to the unique needs of SaMD and other medical devices with software.
0 hr 15 min
QMS SAMD Initial QMS Procedures QMS Refinement & Regulatory Submissions Standard (Free)
How to Implement a Quality Culture
How to Implement a Quality Culture
There’s a difference between meeting quality regulatory standards and fostering a quality culture in your company, and this micro-learning will help us think about how to make sure we are doing the latter.
0 hr 15 min
Quality Management Standard (Free) Course
Understanding UDI
Understanding UDI
Our partners Reed Tech shed light on the global requirements surrounding UDI and share several helpful resources to keep you compliant in this area.
UDI Standard (Free)
Adhering to and Preparing for Changing Clinical Requirements Around the Globe
Adhering to and Preparing for Changing Clinical Requirements Around the Globe
A talk by Jon Ingi Bergsteinsson M.Sc., Matt Wagener and Alethea Wieland: SMART-TRIAL, Proxima Clinical Research, Inc and Clinical Research Strategies, LLC
1 hr 2 min
EU MDR ISO 13485 QMS FDA Regulatory Management QMS Refinement & Regulatory Submissions Clinical Webinar
AMA on Quality Communication
AMA on Quality Communication
A conversation with Lesley Worthington, J.D. about best practices for communicating as a quality professional.
Quality Management Podcast
AMA Session on Clinical Investigations with Smart Trial
AMA Session on Clinical Investigations with Smart Trial
This weeks topic is on Clinical Trials with Jón Ingi Bergsteinsson & Páll Jóhannesson from Smart Trial.
Clinical SMART-TRIAL Standard (Free) Podcast
AMA session on Contract Manufacturing with Mark Rutkiewicz from Innovize
AMA session on Contract Manufacturing with Mark Rutkiewicz from Innovize
This weeks topic is over the Contract Manufacturing for Medical Devices. We hope you enjoy!
QMS manufacturing Supplier Management Quality Management Product Development Standard (Free) Podcast
AMA session on MDSAP with Danny Kroo from Docusys
AMA session on MDSAP with Danny Kroo from Docusys
This weeks topic is over the Medical Device Single Audit Program (MDSAP). We hope you enjoy!
Audit MDSAP Podcast
AMA session on Regulatory Strategy with Michelle Lott
AMA session on Regulatory Strategy with Michelle Lott
This weeks topic is on Regulatory Strategy with Michelle Lott.
QMS Regulatory Management QMS Refinement & Regulatory Submissions Standard (Free) Podcast
AMA session on Risk Management with Mark Swanson from QRXPartners
AMA session on Risk Management with Mark Swanson from QRXPartners
This weeks topic is Risk Management with Mark Swanson from QRXPartners
Risk Management QMS Product Development QMS Refinement & Regulatory Submissions Podcast
AMA session on SaMD Cybersecurity with Chris Gates from Velentium
AMA session on SaMD Cybersecurity with Chris Gates from Velentium
This weeks topic is over the Cybersecurity for SaMD and is with Chris Gates, author of Medical Device Cybersecurity, and Director of Product Security at Velentium. Chris is considered throughout the industry to be a thought leader in all aspects of medical device cybersecurity.
QMS cybersecurity Quality Management Initial QMS Procedures Product Development Standard (Free) Podcast
AMA session on Special Controls with Mike Drues from Vascular Sciences
AMA session on Special Controls with Mike Drues from Vascular Sciences
This weeks topic is over the FDA’s “Special Controls with Mike Drues.
FDA Standard (Free) Podcast
AMA: Join the discussion with the MedTech Excellence Community
AMA: Join the discussion with the MedTech Excellence Community
The MedTech Excellence Community will be hosting AMA (ask me anything) sessions and has invited Academy learners to participate! Ask industry experts, meet your peers, and improve the quality of life by adding your voice to the discussion.
Standard (Free) Podcast
Balancing Innovation & Regulation: Navigating Design Development While Keeping Quality and Regulatory in Mind
Balancing Innovation & Regulation: Navigating Design Development While Keeping Quality and Regulatory in Mind
1 hr 0 min
Design Controls Quality Management Regulatory Management Ideation & Prototyping Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Standard (Free) Webinar
Behind the Stats: 2022 Medical Device Product Development & Quality Management Benchmark Survey
Behind the Stats: 2022 Medical Device Product Development & Quality Management Benchmark Survey
Learn more about our annual survey and the results we've seen from this years respondents. Join Community Manager and Medical Device Guru Etienne Nichols as he unravels the data and shares his perspective on these findings.
0 hr 54 min
Quality Management Product Development QMS Refinement & Regulatory Submissions Product Launch Post-Market Surveillance Webinar
Behind the Stats: Expectations vs. Reality of Bringing a Device to Market
Behind the Stats: Expectations vs. Reality of Bringing a Device to Market
A talk by Etienne Nichols and Radhika Pandya of Greenlight Guru
Standard (Free) Webinar
Common Misconceptions on Medical Device Risk & Design Controls
Common Misconceptions on Medical Device Risk & Design Controls
A talk by Rob MacCuspie: Quality and Regulatory Manager, Proxima Clinical Research
0 hr 54 min
Risk Management Design Controls QMS Initial QMS Procedures QMS Refinement & Regulatory Submissions Webinar
Computer Software Assurance (CSA): Understanding the FDA's New Draft Guidance
Computer Software Assurance (CSA): Understanding the FDA's New Draft Guidance
Francisco Vincenty: Case for Quality Program Manager, FDA
0 hr 50 min
Design Controls QMS 510(k) FDA SAMD Quality Management Regulatory Management Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions USA Computer Software Assurance Standard (Free) Webinar
Connecting Post-Market Studies with Your Commercial Strategy
Connecting Post-Market Studies with Your Commercial Strategy
Speaker: Wojciech Bobela, PhD RAC | Clinical Affairs Manager at Ziemer Opthalmics Snorri Helgason | Director of Market Access at Nox Medical
0 hr 48 min
Funding Post-Market Surveillance Regulatory Strategy Standard (Free) Webinar
Design Control 101
Design Control 101
Join our partners from Kapstone medical as they discuss the basics and how to get started with design control for medical devices.
0 hr 48 min
Design Controls Ideation & Prototyping Product Development Webinar
Designing an International Regulatory Strategy: Why do so many get it wrong?
Designing an International Regulatory Strategy: Why do so many get it wrong?
A talk by Michael Drues PhD and Etienne Nichols Vascular Sciences and Greenlight Guru
0 hr 50 min
CAPA Change Management Audit EU MDR IVDR ISO 13485 Device Classification 510(k) ISO 14971 FDA MDSAP Regulatory Management QMS Refinement & Regulatory Submissions Standard (Free) Webinar
Documenting Risk Management to Meet Requirements of ISO 14971:2019
Documenting Risk Management to Meet Requirements of ISO 14971:2019
A session by Edwin Bills, Consultant
0 hr 50 min
ISO 14971 Regulatory Management Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Product Launch Post-Market Surveillance Standard (Free) Webinar
eMDR Program and Process
eMDR Program and Process
Alireza Hemmati: Senior Product Assessment, TÜV SÜD
0 hr 47 min
EU MDR QMS Quality Management Regulatory Management Initial QMS Procedures QMS Refinement & Regulatory Submissions EU Standard (Free) Webinar
Essentials for Clinical Evaluation of Medical Devices
Essentials for Clinical Evaluation of Medical Devices
The Globiox team will discuss how the latest updates to EU MDR & IVDR may impact your approach to post-market clinical follow-ups, how to optimally demonstrate equivalency in your report, and how to establish a continuous follow-up process for post-market.
0 hr 53 min
Initial QMS Procedures QMS Refinement & Regulatory Submissions Clinical Standard (Free) Webinar
EU MDR: Are you on Pace?
EU MDR: Are you on Pace?
A talk by Adnan Ashfaq, Michael Galliker, Laurie Rowe and Craig Story: Simplimedica, Regulatory Globe, RED Medtech and UDICAAS
0 hr 47 min
EU MDR IVDR Regulatory Management QMS Refinement & Regulatory Submissions Standard (Free) Webinar
Europe's First Device Regulations: A Look Into Manufacturers' Response to the Delay, Transition, & Implementation Process
Europe's First Device Regulations: A Look Into Manufacturers' Response to the Delay, Transition, & Implementation Process
Jon Speer, Founder of Greenlight Guru, will dive into key data and findings from Greenlight Guru's upcoming EU MDR Report, which surveyed hundreds of medical device professionals from all over the world.
0 hr 57 min
QMS Refinement & Regulatory Submissions Product Launch Post-Market Surveillance Standard (Free) Webinar
FDA Today - EUA & SaMD
FDA Today - EUA & SaMD
A talk by Allison Komiyama PhD and Michael Nilo: RQM+ President and Principal Consultant
0 hr 51 min
FDA SAMD cybersecurity QMS Refinement & Regulatory Submissions Webinar
FDA vs EU Requirements
FDA vs EU Requirements
Speaker: Carolyn Algar Guthrie, MS RAC | Regulatory & Quality at Kapstone Medical
0 hr 49 min
EU MDR FDA Regulatory Management QMS Refinement and Regulatory Submission Standard (Free) Webinar
How Electronic Data Capture Is Transforming the MedTech Industry
How Electronic Data Capture Is Transforming the MedTech Industry
A Talk by Jon Bergsteinsson, Autumn Dawn Lang PhD, RAC and Rianne Tooten: Greenlight Guru, VeriSkin Inc. and Rianne Tooten
Standard (Free) Webinar
How Risk Management Can Help Drive Innovation
How Risk Management Can Help Drive Innovation
A session by Michael Quinn, Vice President of Design and Engineering at HS Design
0 hr 46 min
Ideation & Prototyping Product Development Webinar
How to Embrace Risk for Safer Devices
How to Embrace Risk for Safer Devices
Check out one of our favorite podcast episodes from the Global Medical Device Podcast with Tim Moulton, Founder and President at Motim Industries
Risk Management Ideation & Prototyping Product Development QMS Refinement & Regulatory Submissions Standard (Free) Podcast
How to Implement Risk Management into Regulatory Submissions Using Tips, Tricks, and Standards to Satisfy FDA Concerns
How to Implement Risk Management into Regulatory Submissions Using Tips, Tricks, and Standards to Satisfy FDA Concerns
A session by Mary McNamara-Cullinane. Senior Vice President of Regulatory Affairs, Alira Health.
0 hr 47 min
Product Development QMS Refinement & Regulatory Submissions Standard (Free) Webinar
How to Maintain a QMS Compliant to MDR & IVDR
How to Maintain a QMS Compliant to MDR & IVDR
Your QMS should be your source of truth, but what happens when the requirements for a QMS change? Get equipped to meet EUMDR and IVDR standards by checking out this talk from Kyle Rose.
0 hr 52 min
Initial QMS Procedures QMS Refinement & Regulatory Submissions Post-Market Surveillance Webinar
How to Map Agile Processes for Medical Device Design Control Using SCRUMBAN Framework
How to Map Agile Processes for Medical Device Design Control Using SCRUMBAN Framework
Speaker: Tanima Ghosh | Principal Medical Device Consultant at Enerxen Consulting Inc.
0 hr 51 min
Design Controls Ideation & Prototyping Initial QMS Procedures Product Development Standard (Free) Webinar
How to Prepare for Common MDR Audit Pitfalls
How to Prepare for Common MDR Audit Pitfalls
A session by Bassil Akra, CEO and Co-Owner, QUNIQUE GmbH
0 hr 53 min
Initial QMS Procedures QMS Refinement & Regulatory Submissions Product Launch Post-Market Surveillance Standard (Free) Webinar
How to Successfully Plan a Medical Device Product Development Project
How to Successfully Plan a Medical Device Product Development Project
A session by Peter Sebelius, Founder at Medical Device HQ
0 hr 46 min
Product Development Webinar
Insights on the MedTech Regulatory and Clinical Environment in Israel
Insights on the MedTech Regulatory and Clinical Environment in Israel
A talk by Adi Ickowicz Engineer, IQVIA MedTech
0 hr 45 min
QMS Regulatory Management QMS Refinement & Regulatory Submissions Clinical Webinar
Introducing Health Economics in Your Pre-Market Clinical Studies
Introducing Health Economics in Your Pre-Market Clinical Studies
Speaker: Pall Johannesson | Managing Director at Greenlight Guru
0 hr 50 min
Clinical Clinical Trials Pre-Market Standard (Free) Webinar
ISO 13485: What's Next?
ISO 13485: What's Next?
Chandler Thames: Director of Quality, Rook Quality Systems
0 hr 47 min
ISO 13485 QMS Quality Management Regulatory Management Initial QMS Procedures QMS Refinement & Regulatory Submissions Webinar
ISO 14971 Risk Management for Medical Devices
ISO 14971 Risk Management for Medical Devices
Use this guide to align with the latest version of ISO 14971 and to learn additional tips and insights for medical device risk management.
Risk Management QMS ISO 14971 Ideation & Prototyping Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Product Launch Post-Market Surveillance eBook
Key Milestones: How to Know When You're Ready for Your Next Round of Funding
Key Milestones: How to Know When You're Ready for Your Next Round of Funding
A session by David Cassak and Casey McGlynn of Medtech Strategist and WSGR
0 hr 43 min
Funding Ideation & Prototyping Post-Market Surveillance Standard (Free) Webinar
Key Trends Shaping the Future of Medtech Innovation & Investment
Key Trends Shaping the Future of Medtech Innovation & Investment
A session by Paul Grand and Glenn Snyder from Medtech Innovator and Deloitte
0 hr 53 min
Funding Ideation & Prototyping Post-Market Surveillance Standard (Free) Webinar
Latin American Regulations - What you Don't Know
Latin American Regulations - What you Don't Know
A talk by Marcelo Brisolla and Josué Garza: Brisa Advisors and Insumos para la Salud, S.A. de C.V.
0 hr 51 min
QMS Regulatory Management QMS Refinement & Regulatory Submissions Standard (Free) Webinar
Lessons Learned: MedTech Executives on the Fundraising Process
Lessons Learned: MedTech Executives on the Fundraising Process
Join this experience-packed panel as they discuss medical device fundraising and how to navigate this important part of your medtech journey.
0 hr 48 min
Funding Ideation & Prototyping Post-Market Surveillance Standard (Free) Webinar
Leveraging Modern Software Technologies: MedTech’s Best Kept Secret
Leveraging Modern Software Technologies: MedTech’s Best Kept Secret
A Talk by Damini Agarwal, Som Pathak, Michael Roberts and Maxime Rochon: Infinite Biomedical Technologies, LLC., NSV, SPK and Associates and Puzzle Medical Devices
Webinar
Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and your QMS
Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and your QMS
A talk by Joanne Lebrun: Vice President of Quality, MDC Associates, Inc.
0 hr 56 min
EU MDR ISO 13485 QMS FDA Quality Management Regulatory Management QMS Refinement & Regulatory Submissions Standard (Free) Webinar
Managing Changes to Medical Device QMS
Managing Changes to Medical Device QMS
This white paper provides an overview into some of the major changes happening right now, and provides some recommendations to consider when managing these changes. It covers changes to ISO 13485:2016, the EU Medical Device Regulation and In Vitro Diagnostic Device Regulation.
EU MDR IVDR ISO 13485 Initial QMS Procedures Post-Market Surveillance eBook
Market Access Strategy
Market Access Strategy
A session by Leslie Wise, CEO and Managing Director at evidencematters
0 hr 40 min
Ideation & Prototyping Webinar
Marketing Your Medical Device
Marketing Your Medical Device
Speaker: Mark DuVal | CEO & President of Duval Associates
0 hr 50 min
Post-Market Surveillance Webinar
MDR by the Numbers: Leveraging New Data for Implementation Planning
MDR by the Numbers: Leveraging New Data for Implementation Planning
After the wake of the initial and then the first extension of the MDR deadline, the EU regulatory landscape is still reeling from the new requirements. Now facing the possibility of another extension, the medical device industry is further confused not only about requirements themselves but also if and when they must comply.
1 hr 27 min
EU MDR Webinar
MDR Date of Application Roundup: The New Landscape for Medical Device Manufacturers
MDR Date of Application Roundup: The New Landscape for Medical Device Manufacturers
A session by Evangeline Loh, VP of Regulatory Affairs at Emergo by UL
0 hr 47 min
Product Development QMS Refinement & Regulatory Submissions Post-Market Surveillance Standard (Free) Webinar
MDR with Brexit: How the Combination is Impacting the European Medical Device Industry
MDR with Brexit: How the Combination is Impacting the European Medical Device Industry
In this presentation we will be discussing the status of the medical device industry regarding MDR and Brexit, and what are others doing to get ready.
0 hr 53 min
Webinar
MDSAP Certification: Success and Failures
MDSAP Certification: Success and Failures
A talk by Danny Kroo President, Docusys Corporation
0 hr 48 min
Audit MDSAP Regulatory Management QMS Refinement & Regulatory Submissions Standard (Free) Webinar
Moving up to the State of the Art in Risk Management
Moving up to the State of the Art in Risk Management
Ed Bills: ASQ Fellow, RAC, Consultant: Edwin Bills Consulting
0 hr 52 min
Risk Management QMS ISO 14971 Quality Management Regulatory Management Initial QMS Procedures QMS Refinement & Regulatory Submissions Standard (Free) Webinar
Navigating APAC Regulations for Medical Device Companies
Navigating APAC Regulations for Medical Device Companies
A talk by Pierre Lonchampt, Andrew See and Andrew Wu: Diapason Consulting, Medipro Consultancy and Services and Rook Quality Systems
0 hr 52 min
QMS Regulatory Management QMS Refinement & Regulatory Submissions APAC Standard (Free) Webinar
Navigating Uncertainty_ Quality, Regulatory & Clinical Strategies to Accelerate Medical Device Approval
Navigating Uncertainty_ Quality, Regulatory & Clinical Strategies to Accelerate Medical Device Approval
Speaker: Ruba Sarris Sawaya | CEO at MediStrat360 LLC
0 hr 50 min
Quality Management Regulatory Management Clinical Webinar
Panel: Funding and Go to Market Challenges for FemTech
Panel: Funding and Go to Market Challenges for FemTech
Join us for this powerful conversation about the particular challenges facing FemTech founders and companies in the current landscape.
1 hr 0 min
Funding Ideation & Prototyping Webinar
Prepare Now for the EUDAMED UDI/Registration Module
Prepare Now for the EUDAMED UDI/Registration Module
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations for the upcoming EUDAMED UDI/Registration Module.
0 hr 59 min
Initial QMS Procedures QMS Refinement & Regulatory Submissions Product Launch Webinar
Preparing a Device Master Record (DMR)
Preparing a Device Master Record (DMR)
Speaker: Stephen Coulter, Ph.D. | General Manager at RCA
0 hr 48 min
Design Controls Product Development Device Master Record (DMR) Webinar
Product Showcase: Greenlight Guru Academy Advance
Product Showcase: Greenlight Guru Academy Advance
0 hr 9 min
Training Greenlight Guru Platform Standard (Free) Webinar
QMS from a Regulatory Perspective
QMS from a Regulatory Perspective
Carmen Brown: Regulatory Affairs Manager, Proxima Clinical Research
0 hr 48 min
QMS Regulatory Management Initial QMS Procedures QMS Refinement & Regulatory Submissions Standard (Free) Course
QMSR Harmonization - The Good the Bad and the Ugly
QMSR Harmonization - The Good the Bad and the Ugly
A talk by Seyed Khorashahi Executive VP of Medical Devices and CTO, Regulatory Compliance Associates (RCA)
0 hr 50 min
Audit ISO 13485 510(k) FDA Regulatory Management QMS Refinement & Regulatory Submissions Standard (Free) Webinar
QMSR Harmonization: The Future of FDA's Quality Management System Regulation
QMSR Harmonization: The Future of FDA's Quality Management System Regulation
A talk by Dr. Deepa Pandia: NAM Auditing Department Manager, TÜV SÜD
0 hr 53 min
QMS FDA Quality Management Initial QMS Procedures QMS Refinement & Regulatory Submissions Standard (Free) Webinar
Reducing Friction Between Companies and Regulatory Bodies
Reducing Friction Between Companies and Regulatory Bodies
A talk by Simon Wieser: Project Leader and Auditor for MDR and MDSAP, TÜV SÜD
0 hr 49 min
EU MDR IVDR QMS Regulatory Management QMS Refinement & Regulatory Submissions Standard (Free) Webinar
Regulatory & Product Development: Relationship Counseling Course
Regulatory & Product Development: Relationship Counseling Course
A talk by Carolyn Algar Guthrie MS RAC, Carrie Hetrick, Dylan Horvath and Justin Matchett: Kapstone, Sterling Medical Devices, Cortex Deisgn and HS Design
0 hr 49 min
QMS Regulatory Management Product Development QMS Refinement & Regulatory Submissions Webinar
Risk Management According to EU MDR or ISO 14971?
Risk Management According to EU MDR or ISO 14971?
A session by Peter Sebelius, Founder at Medical Device HQ
0 hr 53 min
ISO 14971 Regulatory Management Ideation & Prototyping Product Development QMS Refinement & Regulatory Submissions Product Launch Standard (Free)
Risk Management for Executives: Why Does it Matter to Me?
Risk Management for Executives: Why Does it Matter to Me?
A session by Michael Cremeans, Life Sciences Industry Practice Leader at Hylant
0 hr 44 min
Webinar
Risks that No One Wants to Talk About: Theoretical Risk Management vs. Life in the Real World
Risks that No One Wants to Talk About: Theoretical Risk Management vs. Life in the Real World
A session by Mike Drues Ph.D., President at Vascular Sciences
0 hr 55 min
Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Product Launch Standard (Free) Webinar
Scaling Manufacturing_ 12 Key Questions
Scaling Manufacturing_ 12 Key Questions
Speaker: Dan Purvis | CEO and Co-Founder at Velentium
0 hr 50 min
manufacturing Webinar
SEEDing Biomedical Innovation: Support for Small Businesses at NIH
SEEDing Biomedical Innovation: Support for Small Businesses at NIH
This session will highlight NIH’s strategic focus on early product development, resources, and opportunities available to small business innovators.
0 hr 46 min
Funding Ideation & Prototyping Webinar
So You Think You Want to go to Europe? Considerations for Early Adopters of MDR
So You Think You Want to go to Europe? Considerations for Early Adopters of MDR
A session by Michelle Lott, Regulatory Strategist, Principal, and Founder at Lean RAQA
0 hr 46 min
EU MDR Initial QMS Procedures Standard (Free) Webinar
State of Swexit/Brexit
State of Swexit/Brexit
A talk by Matthias Bissig and Patricia Vest from Inmedis and MDSSPRO
0 hr 49 min
EU MDR IVDR ISO 13485 Regulatory Management QMS Refinement & Regulatory Submissions Webinar
Strategies to Limit Project Timeline and Cost in Medical Devices
Strategies to Limit Project Timeline and Cost in Medical Devices
A session by Milton Yarberry, Director of Medical Programs at ICS
0 hr 50 min
Ideation & Prototyping Initial QMS Procedures Product Development Product Launch Webinar
Supply Chain Management under the MDR, Brexit and Swixit
Supply Chain Management under the MDR, Brexit and Swixit
As a result of the MDR, Brexit and Swixit, manufacturers need to be fully aware of how these changes may impact their current and future supply chain Europe.
0 hr 49 min
Initial QMS Procedures Product Launch Post-Market Surveillance Standard (Free) Webinar
Talent Management Strategies: “Design Quality” for Commercialization
Talent Management Strategies: “Design Quality” for Commercialization
Speaker: Darwin Shurig | CEO & Founder at Shurig Solutions
0 hr 53 min
Design Controls Quality Management Product Development Webinar
The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in 2023
The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in 2023
A Talk by Carlos Almeida, Amanda Feddersen, Weronika Michaluk and David Shanes: SPK and Associates, Monitored Therapeutics Inc., HTD and Fullpower Technologies Inc.
Standard (Free) Webinar
The Global Guide to Human Factors and Usability Engineering Regulations
The Global Guide to Human Factors and Usability Engineering Regulations
A talk by Bryant Foster Sr. VP of Human Factors & UX, Research Collective
0 hr 53 min
Usability Engineering Standard (Free) Webinar
The Importance of Product Classification to Regulatory Strategy
The Importance of Product Classification to Regulatory Strategy
A session by Daryl Wisdahl, Senior Consultant, Quality and Regulatory Affairs at Emergo by UL
0 hr 51 min
Device Classification Regulatory Management Ideation & Prototyping QMS Refinement & Regulatory Submissions Standard (Free) Webinar
The Intersection of Medical Device Usability and Risk Management
The Intersection of Medical Device Usability and Risk Management
Mike Drues joins the podcast again to talk some more about Risk Management
Risk Management ISO 14971 Product Development QMS Refinement & Regulatory Submissions Standard (Free) Podcast
The Most Common Mistakes Health Tech Founders Make When Pitching
The Most Common Mistakes Health Tech Founders Make When Pitching
A session by Adam Dakin, Managing Director at DreamIt Ventures
0 hr 50 min
Ideation & Prototyping Standard (Free) Webinar
The New MDR: Is it Really New and Do We Really Need It?
The New MDR: Is it Really New and Do We Really Need It?
A session by Mike Drues Ph.D., President at Vascular Sciences
1 hr 5 min
Initial QMS Procedures QMS Refinement & Regulatory Submissions Product Launch Webinar
The Path to Commercialization is No Easy Feat: Critical Milestones and Challenges
The Path to Commercialization is No Easy Feat: Critical Milestones and Challenges
Bringing a device to market? This panel discussion will give you a lot to think about and probably help you avoid many pitfalls along the way.
1 hr 2 min
Funding Quality Management Regulatory Management Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Product Launch Standard (Free) Webinar
The Risk Management + Design Controls Connection: What Device Makers Need to Know
The Risk Management + Design Controls Connection: What Device Makers Need to Know
Greenlight Guru found Jon Speer discusses why design controls and risk management should flow and blend together, and it’s important to establish this flow early in product development.
Risk Management Design Controls Product Development Standard (Free) eBook
The Road to 2024: Regulatory Risks Related to Changed Post-Market Surveillance Requirements and Notified Body Certification
The Road to 2024: Regulatory Risks Related to Changed Post-Market Surveillance Requirements and Notified Body Certification
The presentation examines the post-Date of Application period, including - The MDR has more detailed formal PMS requirements.
0 hr 51 min
Regulatory Management QMS Refinement & Regulatory Submissions Standard (Free) Webinar
The ROI of Shifting Mindset From Compliance to Quality
The ROI of Shifting Mindset From Compliance to Quality
A Talk by Edwin Chung, Aaron Gifford, Daniel Powell and Jeff Schwegman: SPK and Associates, Nectar, Spark Biomedical and Recovery Force
Standard (Free)
UDI - US vs EU: What You Need to Know
UDI - US vs EU: What You Need to Know
A talk by John Lorenc and Gary Saner: Reed Tech and LexisNexis Reed Tech
0 hr 45 min
EU MDR FDA UDI Regulatory Management QMS Refinement & Regulatory Submissions Standard (Free) Webinar
UDI and Device Registration, Another Launch Checkbox
UDI and Device Registration, Another Launch Checkbox
A session by Gary Saner, Sr Mgr of Information Solutions at Reed Tech
0 hr 49 min
UDI QMS Refinement & Regulatory Submissions Post-Market Surveillance Webinar
Unannounced Audits by Your Notified Body
Unannounced Audits by Your Notified Body
Speaker: Umesh Soni | Lead Auditor at TÜV SÜD
0 hr 48 min
Audit EU MDR Post-Market Surveillance Webinar
US FDA 101
US FDA 101
A session by Carolyn Guthrie, Director QA/RA at Kapstone Medical
0 hr 49 min
510(k) FDA Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Product Launch Webinar
What Role Should Quality Play in Bringing a Device to Market?
What Role Should Quality Play in Bringing a Device to Market?
A session by Jon Speer, Founder at Greenlight Guru
0 hr 50 min
Ideation & Prototyping Product Launch Standard (Free) Webinar
What to do when FMEA is Not Sufficient Anymore
What to do when FMEA is Not Sufficient Anymore
A session by Peter Sebelius, Founder at Medical Device HQ
0 hr 48 min
Product Development Standard (Free) Webinar
Who Owns Risk Management and How Does it Impact the Business?
Who Owns Risk Management and How Does it Impact the Business?
A session by Jon Speer, Founder at Greenlight Guru
1 hr 1 min
Ideation & Prototyping Product Development Function Webinar
Why You Need to Use IEC 62304 for Software Development
Why You Need to Use IEC 62304 for Software Development
A session by Cathy Wilburn, Director of Quality Assurance and Compliance, The RND Group
0 hr 48 min
SAMD Ideation & Prototyping Product Development Standard (Free) Webinar
Winning Hearts, Changing Minds: How to Build a Risk-Aware Culture in Medtech
Winning Hearts, Changing Minds: How to Build a Risk-Aware Culture in Medtech
Speaker: Christie Johnson | Partner at Prodct
0 hr 50 min
Risk Management Standard (Free) Webinar
Basic Molecular Biology Module 1: Basic Science
Basic Molecular Biology Module 1: Basic Science
The basic-level eLearning course provides information on the fundamental characteristics of DNA and RNA, nucleotide base-pairing rules, and the basic techniques and workflow applied in molecular diagnostics.
0 hr 50 min
Clinical Clinical Trials Lab Best Practices Course
Basic Molecular Biology Module 2: Laboratory Practice
Basic Molecular Biology Module 2: Laboratory Practice
This basic-level eLearning course provides information on general laboratory practices. Topics covered include biosafety practices, laboratory area flow, and practices to minimize contamination.
0 hr 50 min
Clinical Clinical Trials Lab Best Practices Course
Basic Molecular Biology Module 3: Nucleic Acid Extraction
Basic Molecular Biology Module 3: Nucleic Acid Extraction
This basic-level eLearning course, Module 3, provides information on nucleic acid extraction. Topics covered include extraction method selection, basic extraction steps, and nucleic acid analysis.
0 hr 50 min
Lab Best Practices Course
Basic Molecular Biology Module 4: PCR and Real-Time PCR
Basic Molecular Biology Module 4: PCR and Real-Time PCR
This basic-level eLearning course provides information on the principle of PCR and real-time PCR. Topics covered include PCR steps, PCR product analysis, and real-time PCR characteristics.
0 hr 50 min
Lab Best Practices Standard (Free) Course
Fundamentals of Centrifuge Safety
Fundamentals of Centrifuge Safety
This basic-level eLearning course provides information on the safe use of centrifuges. Topics covered include major parts of a centrifuge, types of centrifuges, potential hazards, how to work safely with a centrifuge, and what to do if there is an emergency.
0 hr 50 min
Lab Best Practices Standard (Free) Course
Fundamentals of Chemical Fume Hood Safety
Fundamentals of Chemical Fume Hood Safety
This basic-level eLearning course provides an essential understanding of the major components of a chemical fume hood and proper practices for its safe and effective operation.
0 hr 50 min
Lab Best Practices Course
Fundamentals of Working Safely in a Biological Safety Cabinet
Fundamentals of Working Safely in a Biological Safety Cabinet
This basic-level eLearning course provides information on the safe use of Class II biological safety cabinets.
Limited Availability
0 hr 50 min
Lab Best Practices Course

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