Webinar

How to Prepare a Medical Device CE Marking Submission

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.

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Advanced Product Registration Techniques for Faster Global Access

bennyIn 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.

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How to Get an Insurer to Reimburse Your Medical Device

robert-packardDeciding 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.

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How to Prepare a Medical Device 510(k) Submission for FDA

robert-packardThis 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!

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How to Qualify and Choose a Medical Translations Agency

peter-argondizzoPeter 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.

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How to Simplify Your Compliance with the New ISO 13485:2016

speerJon 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.

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How to Complete Your UDI Compliance by September 2016

udi reed technologyBy 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!

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Compliance Risks for Medical Device Manufacturers

Anne ComplianceIn 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.

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How to Use All That UDI Data You Submitted

LorencSince 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.

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Predictable and Repeatable Medical Device Sales

Mike Sperduti medical device salesIn 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.

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How the Global EPR Fee-Paying Regulations Impact Your Business

Lorax Compliance Emma MundyIf 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.

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Class II Device Makers: UDI Mistakes You Can Avoid

udi reed technologyIf 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.

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Impact of the New CE Marking Rules in Europe

akraNew CE Marking rules are a’comin. If you do business in the European Union, you’ll want to review this important content.

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A “Risk-Based Approach” to QMS Ahead of ISO 13485 Changes

speer16-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.

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Time’s Up! Mandatory Unique Device Identification Starts September 2015

udi reed technologyCome 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.

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How to Prepare a 510(k) Submission for the FDA

robert-packardQA/RA subgroup leader Rob Packard will give you valuable tips you need for a smooth 510(k) submission to FDA.

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How To Increase Market Share Using Medical Claims Data

Dom DeStefano LexisNexisDon 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.

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Medical Device Single Audit Program (MDSAP)

Edna FalkenbergA 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.

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Designing Health for Consumers

Tom KraMer KablooeA free webinar for product, project, and R&D directors working on the creation of connected solutions for patient monitoring, scheduling, tracking, or drug delivery.

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12 Steps for Accurate Medical Device UDI Submissions to the FDA GUDID

udi reed technologyA 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.

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A Look at Current Medical Device Company Websites

Medical Devices Group Leader Joe HageMedical 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.

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Big Changes in Australia for Medical Devices

Arthur BrandwoodSydney-based regulatory affairs expert Arthur Brandwood will discuss the recent changes made by the Australian Therapeutic Goods Administration (TGA).

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Selling Medical Devices in this Difficult Healthcare Environment

medical device sellingLearn the medical device selling strategies Mike Sperduti effectively uses for GE Healthcare, Becton Dickinson, and his own medical device company.

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UDI / GUDID: Class III is due September 24

udi reed technologyThird 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.

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UDI / GUDID Webinar: Part II

udi reed technologyBack 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.

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The Medical Device Manufacturers’ Roadmap to Sustainable Innovation

Maureen-Carlson-Appleseed-PartnersThis 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.

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Unique Device Identification (UDI) Requirements and Timelines

udi reed technologyThis 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.

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2014 Medical Device Job Market

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.

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Saving On Labor (without firing anyone or outsourcing)!

Dr. Alex KerinDr. Alex Kerin discusses labor’s impact on transport, inventory, motion, waiting, over-production, over-processing, and defects. Learn how many were caused by labor (human error) and ways to reduce it.

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Best Practices in Medical Device Marketing

Joe HageMedical Devices Group Leader Joe Hage shares contemporary online marketing strategies for medical device companies in the digital age.

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Best Practices in Medical Device Auditing

Robert PackardQA/RA Expert Robert Packard describes the best practices for medical devices auditing.

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How to Crowdsource for Medical Devices

david-bratvoldFounder 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.

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Why Manufacture in Costa Rica?

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.

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Five MedDevice Sales and Marketing Strategies Doomed to Fail Today

Focused on U.S. market dynamics, this webinar includes recommendations you can immediately use to improve your performance this year.

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