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.
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!
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.
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.
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.
CAPA violations are the most frequently observed Quality System subsystem cited by FDA. Jon Speer from Greenlight Guru shows you how to avoid them.
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?
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.
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.
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.
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).
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.
Medical Devices Group Advisory Board member, Intellectual Property Lawyer Doug Limbach will give you free counsel how to protect your patents from competitors.
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.
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.
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.
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!
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.
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.
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!
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.
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.
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.
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.
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.
New CE Marking rules are a’comin. If you do business in the European Union, you’ll want to review this important content.
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.
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.
QA/RA subgroup leader Rob Packard will give you valuable tips you need for a smooth 510(k) submission to FDA.
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.
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.
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.
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.
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.
Sydney-based regulatory affairs expert Arthur Brandwood will discuss the recent changes made by the Australian Therapeutic Goods Administration (TGA).
Learn the medical device selling strategies Mike Sperduti effectively uses for GE Healthcare, Becton Dickinson, and his own medical device company.
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.
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.
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.
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.
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.
Dr. 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.
Medical Devices Group Leader Joe Hage shares contemporary online marketing strategies for medical device companies in the digital age.
QA/RA Expert Robert Packard describes the best practices for medical devices auditing.
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.
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.
Focused on U.S. market dynamics, this webinar includes recommendations you can immediately use to improve your performance this year.