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

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Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA 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

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Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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FREE ON-DEMAND WEBINAR

Demystifying the Breakthrough Device Designation (BDD) & Safer Technologies (STeP) Processes

In recent years, FDA has rolled out two new programs that are designed to expedite the go-to-market process for innovative medical devices:

  • Breakthrough Device Designation (BDD)
  • Safer Technologies Program (STeP)

Both programs offer exciting opportunities for medical device companies, but the application processes for obtaining designation for each contain plenty of nuance.

Isabella Schmitt, Director of Regulatory Affairs at Proxima, is here to help webinar participants demystify BDD and STeP by explaining the application processes and why getting these designations early in the regulatory process can help clear your device’s pathway to approval.

Isabella will help you crack the code using the same methods used with successfully counseling multiple companies through BDD and STeP designation processes, and help you learn what it takes to achieve BDD or STeP designation for your medical device.

Watch the webinar
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Specifically, this webinar will cover:
  • A breakdown of the criteria for each program
  • How to create a successful BDD packet (spoiler alert: it’s not as easy you think)
  • How much information to include in applications – finding the balance between enough,  but not too much
  • Explanation of what “more effective” and “reasonable expectation of clinical and regulatory success” mean in the context of BDD and STeP
  • Types of interactions you should expect to have with each program and how to navigate key relationships successfully
Who Should Attend?
  • Medtech leaders and company founders
  • Regulatory affairs professionals
  • Medical device and diagnostic innovators
  • Medical device professionals interested in learning more about BDD and STeP applications 
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Hosted by

Isabella-Schmitt
Presenter: Isabella Schmitt

Director of Regulatory Affairs, Proxima Clinical Research
Ryan-Behringer
Moderator: Ryan Behringer

Training and Onboarding Medical Device Guru, Greenlight Guru

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About Proxima Clinical Research

You have an innovative medical device or drug, and you need an organization experienced in getting products approved and on the market.  We know your needs. We know the pitfalls of the submission process and how to avoid them.  From regulatory consulting to clinical research, Proxima is the dedicated full-service Contract Research Organization for emerging companies. Visit their website to learn 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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