Remote Patient Monitoring for Urology Has Arrived and Will Change Everything
Recorded Wednesday, May 13, 2020
A webinar for anyone in urology, gynecology, or remote patient monitoring. Strategic players and payors will also learn how this technology will change the face of urology.
Practical FDA Strategies to Avoid Stunning Disaster
Recorded Thursday, October 17, 2019
A webinar for anyone who might submit anything to FDA ever again: Rob Packard will offer practical strategies to help you conserve cash, test smarter, and be better prepared for your all-important FDA submission.
How To Use Medical Claims Data to Grow Your Market and Sales Penetration
Recorded Wednesday, October 9, 2019
Rick Grape and Rebecca Hauck from LexisNexis Risk Solutions have access to claims data including procedures by surgeon, by CPT and ICD code. Would it help you sell more? I think it would. Find out how!
How to Outperform Your Competition Online
Recorded July 9, 2019
Master storyteller, WireBuzz CEO Todd Hartley, explained how to pull your device prospects through your sales funnel faster by integrating tactical business videos into your marketing and sales process.
What You Need to Know Before Manufacturing a Wearable Device
Recorded January 23, 2019
A plenary session from Walt about the steps you need to take to build a better wearable device and get it cleared through FDA.
A Much Easier Way to Access and Use FDA Databases
Recorded December 11, 2018
If you routinely access FDA databases, you know it’s a hassle searching multiple sites and matching the data up get a holistic view of the issue. I think I found a solution and I’m inviting you along to discover it with me.
How to Prepare a Medical Device 510(k) Submission for the FDA
Recorded October 25, 2018
FDA made a lot of changes to the 510(k) process since our last webinar with Rob. Here, he’ll cover imminent changes and share new tips and tricks he learned from dozens of pre-submissions.
FDA Partners with Greenlight Guru: Case for Quality Webinar Series
Four sessions recorded in Sept and October 2018
FDA’s Francisco Vicenty, the Case for Quality Program Manager, shared new CDRH news sure to affect medical device manufacturers. If you make medical devices, do yourself a favor and absorb this easy-to-digest webinar series sponsored by Greenlight Guru.
Everything Device Makers Need to Know About Design Controls
Recorded May 24, 2018
Without tight design controls, how do you prove you designed a safe and effective device that meets the indications for use? Jon Speer will talk about intended use, user needs, design inputs, reviews, DHFs, risk management, and why an FMEA alone for risk management doesn’t cut it anymore.
What’s Your Clinical Evidence Generation Strategy?
Recorded May 15, 2018
Think you need clinical evidence to support your medical device? You probably do. But how much? When? What is the least expensive, least burdensome, and fastest path? I don’t know. But Beth Brooks from Decision Driver Analytics does. Come listen to what she has to say, for free!
How to fix your supply chain before it breaks down
Recorded March 14, 2018
Carlos Soares will share a framework for selling your plan to management, his secret to finding wasteful procurement spending, the attack plan for most business and manufacturing process challenges, and clues how to streamline, reduce wait and lead times.
The Way to Get Your Device Reimbursed in Today’s Payer Environment
Recorded May 2, 2016
Beth Brooks, Nic Anderson, and April Zambelli-Weiner know how to get your device reimbursed better than you do. So listen to what they have to say.
How to Prepare for an FDA Pre-Submission
Recorded May 2, 2016
David Amor and Jon Speer’s advice on 510(k) submissions are invaluable. Srsly, if a 510(k) is even in your periphery, access this presentation. I think you’ll get the most value out of their step-by-step case study example of the pre-sub process.
How to avoid the worst CAPA system pitfalls
Recorded December 12, 2017
CAPA violations are the most frequently observed Quality System subsystem cited by FDA. Jon Speer from Greenlight Guru shows you how to avoid them.
How to Get Past the Value Analysis Committee
Recorded October 24, 2017
Beth Brooks from Decision Driver Analytics showed us how to measure value from a hospital’s perspective. What data elements are important? How do you generate the data? How do you package the information for the VAC?
Leveraging Big Data to Mitigate Medical Device Risks
Recorded August 8, 2017
In this webinar, we’ll examine the available safety and quality data sources, what they can tell us, challenges with analyzing the data, and what you can do to overcome these challenges and help you in your role.
Improving Enterprise Value for the MedTech Executive
Recorded August 1, 2017
If you were asked to name a price at which you’d sell your company, could you do it? Discover an algorithm to assess your enterprise value and, based on your outcome, learn which management decisions will add the most incremental value.
How to Implement and Maintain an Audit-Ready QMS Leveraging Technology
Recorded July 18, 2017
Inefficient systems increase your risk of noncompliance and increase your development time. So we’ll show you a modern, purpose-built software that ensures compliance with all the latest regulations to free up your engineers’ time, reduce risk, time to market, and help you pass audits with flying colors.
Why Your Data Needs to be in the Global Data Synchronization Network (GDSN)
Recorded June 14, 2017
Major customers, including Group Purchasing Organizations and hospital networks, need access to data in a standard format. In this session, we’ll examine how medical device product data is distributed through the Global Data Synchronization Network (GDSN).
Managing Regulatory Standards in Multiple Jurisdictions
Recorded June 6, 2017
If you’re on a regulatory team and presently selling in multiple countries, heed this webinar for all the nuances and dates for managing standards in multiple jurisdictions.
How to Check Your Patents for Loopholes
Recorded February 28, 2017
Medical Devices Group Advisory Board member, Intellectual Property Lawyer Doug Limbach will give you free counsel how to protect your patents from competitors.
How to Prepare a Medical Device CE Marking Submission
Recorded May 2, 2016
In this timely regulatory workshop, Medical Devices Group Advisory Board member Rob Packard, clinical expert and Notified Body representative Bassil Akra will give you a step-by-step process for preparing your CE Marking submission.
Advanced Product Registration Techniques for Faster Global Access
Recorded February 1, 2018
In this free presentation, you’ll learn about a readily available cloud-based solution to expedite product clearances, process multiple registrations in multiple countries on one platform on a fixed budget, keep ownership of your product, and allow in-market sales and marketing activities sooner.
How to Get an Insurer to Reimburse Your Medical Device
Recorded May 2, 2016
Deciding whether medical devices like yours will be reimbursed by InterMountain Health is what Nic does for a living so you know you’re getting the best advice possible. This is the definitive resource for anyone looking to wade through the reimbursement quagmire.
How to Prepare a Medical Device 510(k) Submission for FDA
Recorded May 2, 2016
This is a 2.5-hour workshop explained the format of a 510(k), how to manage 510(k) projects, and what the requirements are for hardware and software product submissions. A must if you’re planning your own 510(k) submission!
How to Qualify and Choose a Medical Translations Agency
Recorded November 2, 2016
Peter Argondizzo will deliver this webinar for anyone tasked with managing the translation effort for their organization. Beginners and Advanced buyers of translation will benefit from this presentation.
How to Simplify Your Compliance with the New ISO 13485:2016
Recorded October 4, 2016
Jon Speer, an 18+ year medical device industry veteran and founder & VP QA/RA at greenlight.guru, will walk us through all the changes ISO made in its long awaited revision to 13485, the global standard for medical device quality management systems.
How to Complete Your UDI Compliance by September 2016
Recorded June 8, 2016
By now you probably know that Class II device labelers have to comply with the FDA’s Unique Device Identification (UDI) mandate by September 24 of this year. If you didn’t know that and your organization labels Class II devices, you have some catching up to do!
Compliance Risks for Medical Device Manufacturers
Recorded April 28, 2016
In this free event, Anne Barr from The Compliance Map will tell you how to avoid the penalties associated with cracks in your environmental compliance procedures.
How to Use All That UDI Data You Submitted
Recorded April 6, 2016
Since you’re doing the work anyway, you may as well use your UDI data downstream. Smart device labelers are using the data records they submit to the FDA to update their own internal processes and systems. UDI expert John Lorenc will show you how.
Predictable and Repeatable Medical Device Sales
Recorded March 31, 2016
In this webinar, Mike Sperduti shared his predictable and repeatable process that will launch your new technology and quickly ramp your sales, build the best database in your space, build a sustainable sales pipeline, and dramatically lower your sales expense.
How the Global EPR Fee-Paying Regulations Impact Your Business
Recorded January 26, 2016
If you’re not completely sure how to comply with all packaging, waste electrical and electronic equipment (WEEE), and battery recycling regulations, this will be a very well-spent hour for you. Lorax Compliance expert Emma Mundy’s advice can keep you clear of unnecessary fines and bad publicity.
Class II Device Makers: UDI Mistakes You Can Avoid
Recorded December 10, 2015
If you market a Class II device in the U.S., you’ll need to report your Device Identifier by September 24, 2016. And Gary’s noticed a distinct pattern between (a) applications that sail through FDA GUDID and (b) applications that get sent back.
Impact of the New CE Marking Rules in Europe
Recorded October 6, 2015
New CE Marking rules are a’comin. If you do business in the European Union, you’ll want to review this important content.
A “Risk-Based Approach” to QMS Ahead of ISO 13485 Changes
Recorded September 29, 2015
16-year medical device industry veteran, QA/RA consultant, and founder of eQMS software platform greenlight.guru, Jon Speer will give product developers and manufactures a thorough insight into the specific risk-based changes they’ll need to understand to comply with the purposed standard.
Time’s Up! Mandatory Unique Device Identification Starts September 2015
Recorded June 9, 2015
Come September 24, 2015, all medical device manufacturers of Implants, life-sustaining, and life-supporting devices marketed in the U.S. need to submit unique device identifiers to the FDA. Learn what’s required.
How to Prepare a 510(k) Submission for the FDA
Recorded June 4, 2015
QA/RA subgroup leader Rob Packard will give you valuable tips you need for a smooth 510(k) submission to FDA.
How To Increase Market Share Using Medical Claims Data
Recorded May 19, 2015
Don DeStefano from LexisNexis Health Care will discuss the most important data he collects: Procedures by surgeon, by CPT and ICD-9 code – and explain how you can use this information to target docs with the highest volumes in your product line.
Medical Device Single Audit Program (MDSAP)
Recorded April 28, 2015
A free webinar to understand the impact of the Medical Device Single Audit Program will have on Medical Device Manufacturers selling into the USA, Canada, Brazil or Australia.
Designing Health for Consumers
Recorded March 3, 2015
A free webinar for product, project, and R&D directors working on the creation of connected solutions for patient monitoring, scheduling, tracking, or drug delivery.
12 Steps for Accurate Medical Device UDI Submissions to the FDA GUDID
Recorded January 21, 2015
A must for members of your team who are responsible for device labelling. Implantable, life-supporting and life-sustaining (I/LS/LS) devices, including stand-alone software (and the direct marking of these devices, for certain intended uses) are subject to the regulation, come September 2015.
A Look at Current Medical Device Company Websites
Recorded December 18, 2014
Medical Devices Group Leader Joe Hage reviews how 33 life science company websites evolved over the past two years and gives you a PDF of the screen shots.
Big Changes in Australia for Medical Devices
Recorded November 18, 2014
Sydney-based regulatory affairs expert Arthur Brandwood will discuss the recent changes made by the Australian Therapeutic Goods Administration (TGA).
Selling Medical Devices in this Difficult Healthcare Environment
Recorded October 2, 2014
Learn the medical device selling strategies Mike Sperduti effectively uses for GE Healthcare, Becton Dickinson, and his own medical device company.
UDI / GUDID: Class III is due September 24
Recorded July 31, 2014
Third in a Series! Very popular and important content hosted by Reed Technology about FDA’s Unique Device Identifier (UDI) and GUDID. Especially relevant if you have a Class III device because the deadline is September 24, 2014.
UDI / GUDID Webinar: Part II
Recorded March 4, 2014
Back by popular demand! A second webinar hosted by Reed Technology about FDA’s Unique Device Identifier (UDI) and GUDID. A must if you or a team member is responsible for labeling at your organization.
The Medical Device Manufacturers’ Roadmap to Sustainable Innovation
Recorded November 12, 2013
This free webinar hosted by Planview and Appleseed Partners discussed how nearly 100 Medical Device Manufacturers assessed their current innovation management capabilities and how they can improve productivity, time-to-market, and commercial success.
Unique Device Identification (UDI) Requirements and Timelines
Recorded October 29, 2013
This excellent webinar hosted by Reed Technology had so many questions about FDA’s Unique Device Identifier (UDI) that we went 30 minutes longer than planned. A must if you need to learn about unique device identification from Medical Devices Group Advisory Board member Gary Saner.
2014 Medical Device Job Market
Recorded October 10, 2013
Paula Rutledge, one of the most influential recruiters in the United States, discussed the U.S. healthcare industry hiring outlook for device, medtech, and diagnostic companies grappling with increased regulation, the 2.3% device tax, ACA provisions, and a candidate-driven market.
Best Practices in Medical Device Marketing
Recorded July 25, 2013
Medical Devices Group Leader Joe Hage shares contemporary online marketing strategies for medical device companies in the digital age.
Best Practices in Medical Device Auditing
Recorded February 13, 2013
QA/RA Expert Robert Packard describes the best practices for medical devices auditing.
How to Crowdsource for Medical Devices
Recorded February 5, 2013
Founder of DailyCrowdsource David Bratvold explains in this practical webinar there’s much more to crowds than funding. Founder of Medstartr Alex Fair discusses crowdfunding. Stephen Paljieg from Kimberly-Clark gives a real-life example.
Why Manufacture in Costa Rica?
Recorded February 25, 2012
Costa Rica has become a hub for medical device and life sciences companies looking for efficiency and productivity. George Blank, Chairman of the Board of Vention Medical, explains how and why he built a facility there. Great questions follow.
Five MedDevice Sales and Marketing Strategies Doomed to Fail Today
Recorded September 23, 2012
Focused on U.S. market dynamics, this webinar includes recommendations you can immediately use to improve your performance this year.