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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

10 Things You Must Know About Updating Your Technical Files To Comply With EU MDR

The new EU MDR will affect all medical device manufacturers doing business in the EU.

The new regulation will bring significant changes with some of the largest coming from what is expected from your technical documentation.

How much remediation will be needed? What steps should you be taking now? What are the new expectations?

In this free 60 minute webinar presented by Sameer Jaiswal, a PRP Consultant & EU MDR SME, you will learn exactly what you need to do with your technical files to comply with the new EU MDR.

Watch the webinar
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Specifically, this webinar will cover:
  • The most important things you must know regarding your technical file to comply with EU MDR
  • Why your technical file must truly be a living document 
  • The new standard for proving equivalence
  • Why you’ll now need to include more detailed QMS requirements
  • How risk management is expected to be integrated
  • And much more
Who Should Attend?
  • Medical Device Executives
  • Regulatory Affairs Professionals and Management
  • Quality Professionals and Management
  • Clinical Affairs Professionals and Management
  • R&D Engineers and Management
 Register Now  

Hosted by

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Presenter: Sameer Jaiswal

Consultant, PRP
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Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru

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About Professional Resource Partners
Since 2012, Professional Resource Partners has been honored to serve as a trusted source of quality and regulatory compliance talent to the medical device and pharmaceutical industries. As a certified woman-owned business, PRP is proud to deliver exceptional professional integrity and a positive customer experience to each of the many clients it supports with its customized consultancy. It’s also the reason why, when PRP is involved, client expectations are not simply met, but they are consistently surpassed.

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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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