Clinical Login Support
Products

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

Learn More

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.

View Product Tour

Data collection and management designed for MedTech clinical trials.

Learn More

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

Get a personalized demo of Greenlight Guru Clinical today.

Request a Demo
Solutions
Why Us
Customers
Partners
Company
Resources
BestQMS-book-mockup-01

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.

View Now
Pricing
Contact Sales Get a Demo
Contact Sales
Get a Demo

FREE ON-DEMAND WEBINAR:
October 20, 2022

How to Prepare for IVDR

The European In Vitro Diagnostic Regulation (EU IVDR) entered into application on May 26, 2022. However, Climedo Health and TRIGA-S Scientific Solutions conducted a survey of manufacturers just a few weeks before the date of application and found that:

•  85% of respondents were still “in the
    middle” of preparation for regulations
•  43% of respondents still did not have a notified body
•  Less than two-thirds of respondents knew the responsibilities
   regarding postmarket surveillance and vigilance


The delays, confusion, and shortage of notified bodies have not made it easy for companies to get their QMS and technical documentation compliant with IVDR. That’s why we’ve teamed up with Rook Quality Systems for this in-depth webinar on steps you can take right now to prepare for the new regulation. 

This educational webinar, presented by Kyle Rose, President of Rook Quality Systems, will provide you with pertinent details and established best practices on how to prepare your QMS, technical, and clinical documentation for the upcoming IVDR regulations.

Watch the webinar
RQS-GG Webinar 10-20-22-1
Specifically, this webinar will:
  • Provide a detailed breakdown of what is needed to get your QMS in compliance for the IVDR regulations.
  • Discuss which devices fall under IVDR, including software that provides diagnostic results.
  • Outline what is required for your clinical and technical files, and how to prepare if you have gaps.
  • Breakdown the process and timeline for getting a notified body, and what to expect for your audit and technical documentation review.
  • Highlight key dates for IVDR compliance, and when to start preparing.

Who should attend?
IVD medical device companies interested in learning about IVDR, which replaces the EU In Vitro Diagnostics Directive (IVDD) 98/79/EC
 Register Now  

Hosted by

Kyle Rose headshot-round
Presenter: Kyle Rose

President,
Rook Quality Systems

Etienne-Nichols-round
Moderator: Etienne Nichols

Medical Device Guru & Community Manager, Greenlight Guru

 

Rook-Logo-08-21-01-1

Rook Quality Systems provides specialized and custom consulting services for all classes of medical devices. We work with you to outline your quality and business goals to develop innovative and efficient practices that improve compliance and profit. You can see a full list of the service offerings from Rook Quality Systems by visiting their website to learn more


greenlight-guru-logo

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

Featured In