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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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FREE ON-DEMAND WEBINAR

Combination Products: What Are They, Why Are They Important & Why Should Medical Device Professionals Care?

Before you stop reading because you think this topic is a no-brainer, think again! Combination products are not nearly as simple or straightforward as so many seem to think.

Consider this: combination products make up more than 30% of all new healthcare products currently under development and the global market for combination products is over $115B!

So, what makes combination products so valuable in today’s healthcare market?

During this webinar, we will explore the seemingly simple question at the root of these unique products: what can combination products do that medical devices, drugs and biologics alone cannot?

Participants will learn through real use cases from a wide range of combination products on the market, under development and on the drawing board. 

Join regulatory expert Michael Drues, Ph.D., in this free, interactive webinar where you'll discuss real products from a variety of clinical specialities such as drug-eluting stents and balloons, pre-loaded syringes and transdermal patches, drug-biologic combinations and companion diagnostics as well as more complex types, like 3-D printing, personalized medicine, tissue engineering and biomedical nanotechnology.

Watch the webinar
M.Drues webinar 6-17-21
Using the case study approach, we’ll address these questions and more in an interactive fashion:
  • What is and is not a combination product? Is it as simple as reading the CFR or is the CFR holding us back?
  • Why are combination products important? Is it just about the money or is there a more important reason?
  • How are combination products regulated? Is it simply a matter of PMOA?
  • What does the future hold? How will tissue engineering, nanotechnology and other “advanced” technologies impact the medical device industry as we know it today?
  • Q&A session

And this is just the tip of the iceberg! Bottom line: combination products found on the market today, while important, are only rough drafts compared to the masterpieces they can become with the right knowledge base, support, and plan.

Who Should Attend?
Geared for both experienced medical technology professionals as well as those new to the industry, this webinar is designed for those who need a better understanding of the current regulatory requirements and concepts around combination products as well as those in the following roles:
  • Product Development Engineers, Scientists and Technicians
  • Regulatory Affairs and Quality Professionals and Management
  • Marketing and Investment Specialists
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Hosted by

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Presenter: Mike Drues

President, Vascular Sciences
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Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru

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About Vascular Sciences
Vascular Sciences has been conducting seminars specifically geared toward medical device design, development and testing since 1996. These seminars have been requested by companies ranging in size from start-up to fortune 100 companies, the European Patent Office and the FDA Centers for Devices and Radiological Health (CDRH). Visit their website tolearn more.

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About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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