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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 CAPA Management Audit Management Product Development

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

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Accelerate development with integrated design control and risk software.

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Featured Capabilities:

Design Controls Risk Management Risk Intelligence

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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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FREE ON-DEMAND WEBINAR

Breakthrough Device Designation & Its Impact on Reimbursement

What you need to know today, tomorrow, and how to prepare for the uncertain future.

Join for a practical discussion on the benefits and risks associated with FDA Breakthrough Designation and what it means for reimbursement, FDA interactions and time to market. What should I know about FDA Breakthrough Device designation so that I can speak intelligently to my team, investors, and customers?

Watch the webinar
Partner Webinar 11.3.21
Specifically, this webinar will cover:
  • Overview of the upcoming breakthrough device designation changes
  • Update on the number of devices that have Breakthrough Designation, what that means for your company’s regulatory journey, and strategies to leverage the program
  • Benefits on Medicare reimbursement for devices with Breakthrough Designation
  • Potential impact Breakthrough Designation on Medicare coverage and discussion on recent changes to the Medicare Coverage of Innovative Technologies (MCIT) rule
  • The future for breakthrough devices
Who Should Attend?
  • Medical Device Executives
  • Regulatory Affairs Professionals and Management
  • Reimbursement Professionals
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Hosted by

Allison Komiyama
Presenter: Allison Komiyama

Principal Consultant and Founder, AcKnowledge Regulatory Strategies
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Presenter: Mark Domyahn

Partner, JD Lymon Group

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About Acknowledge regulatory strategies

AcKnowledge Regulatory Strategies specializes in Regulatory Affairs (RA) consulting exclusively for the medical device and In Vitro Diagnostic (IVD) industry. We understand that each medical device needs a specific and tailored strategy to earn regulatory clearance. For more information, please visit their website by clicking here.

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About JD Lymon Group

Founded by three highly respected healthcare strategists with more than 70 years of combined experience, JD LYMON creates strategic, integrated, multidisciplinary pathways that help medical device and biopharmaceutical companies understand their unique value proposition and optimize their market potential. For more information, please visit their website by clicking here.

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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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