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Greenlight Guru QMS

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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SMART-TRIAL by
Greenlight Guru

Data gathering and management designed for MedTech clinical trials and operations.

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Featured Capabilities:

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

Get a personalized demo of SMART-TRIAL by Greenlight Guru today.

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Greenlight Guru Academy

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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Discover the new trends, outlooks, challenges, and opportunities in the MedTech industry in 2023.

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FREE ON-DEMAND WEBINAR

Top Things You Should Know When Developing Software As A Medical Device (SaMD)

With the rapid innovation in digital health such as Artificial Intelligence, wearable devices, web applications, and more comes and necessitates an evolving regulatory landscape.

The Software as a Medical Device guidance (SaMD) was adopted by the FDA along with global regulatory leaders to ensure such software products adopt the same general medical device principles to demonstrate safety, effectivity and performance. 

This growing subset in the medical device industry introduces many software development companies to the medical device field. However, any company that manufactures SaMD faces rigorous regulatory requirements especially as it relates to their quality management system.  

This free, in-depth webinar will be presented by Shawnnah Monterrey of Beanstock Ventures who will provide a detailed overview of SaMD, the latest updates to the regulations, and how to effectively implement and adapt a QMS for SaMD.

Watch the webinar
Greenlight Guru-BeanStock Ventures Webinar 4-21-22
Specifically, this webinar will cover:
  • Determining if your device and/or software is SaMD
  • Understanding aspects influencing safety, effectivity, and performance
  • Classifying your SaMD amidst the changing regulations
  • Adopting (or adapting) your QMS for SaMD
  • Taking the practical next steps to market
  • Q&A Session
Who Should Attend?
  • Quality Professionals and Management
  • Regulatory Affairs Professionals and Management
  • Software Development Engineers and Management
  • Medical Device Executives
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Hosted by

Shawnnah Monterrey
Presenter: Shawnnah Monterrey

CEO, BeanStock Ventures
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Moderator: Etienne Nichols

Medical Device Guru & Community Manager,

Greenlight Guru

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About BeanStock Ventures

BeanStock Ventures was founded by Shawnnah Monterrey, with the intention of making the development of breakthrough medical devices innovative, predicable, efficient and cost-effective for clients across the globe. Calling upon her own 20+ years experience working as a software development professional in the healthcare and life science space, as well as a skilled team of engineers, designers, quality assurance and other tech professionals with a shared passion for innovation. 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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