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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 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.

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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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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.

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FREE ON-DEMAND WEBINAR
July 27, 2023

Developing IEC 62304 Compliant Software: Proven Tips & Best Practices

In the fast-paced, highly regulated world of medical device manufacturing, achieving compliance with international standards like IEC 62304 is not just a nice-to-have—it's a necessity.

And that's precisely why we've curated this power-packed webinar, designed to unlock your potential to thrive within this crucial regulatory framework.

Join MedTech expert Cathy Wilburn as she demystifies the complexities of implementing IEC 62304, offering a roadmap of best practices for successful medical device software lifecycle management.

You'll gain the knowledge, skills, and strategies necessary to successfully implement IEC 62304, ensuring regulatory compliance while developing superior medical device software.

Don't miss this chance to elevate your medical device software quality while safeguarding regulatory compliance. Register today, and let's forge a path to success together!

Watch the webinar
Greenlight Guru_The RND Group Webinar 7-27-23
Specifically, this webinar will help you:
  • Align with FDA and EU regulatory requirements to ensure that your implementation of IEC 62304 complies with their specific guidelines.
  • Start early, conduct a thorough gap analysis, and develop a plan to address any non-compliance or gaps in your software development processes.
  • Consider utilizing a software development lifecycle model that encourages iteration and evolution.
  • Establish comprehensive process and product documentation.
  • Receive training and promote awareness of IEC 62304 among all personnel involved in software development.
Who should attend? 
  • Regulatory Affairs Professionals & Management
  • Quality Professionals and Management
  • Medical Device Executives
  • Product Development Engineers and Management
 Register Now  

Hosted by

Etienne-Nichols-round
Moderator:
Etienne Nichols

Medical Device Guru,
Greenlight Guru
Cathy-Wilburn
Presenter:
Cathy Wilburn

Director, Quality Assurance and Compliance,
The RND Group, a Gener8 Company

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About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.

RND_Gener8_Logo - Cathy Wilburn

About The RND Group

The RND Group, a Gener8 company, comprises specialized software developers exclusively focused on the intricate craft and processes needed for FDA-regulated medical device software. By employing thoroughly tested frameworks and software components, we effectively reduce the time to market and cost while adding significant value. Over the past 25 years, we have built a strong reputation for successfully delivering superior-quality software for FDA-regulated devices.

 
Visit their website to learn more.

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