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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 LIVE WEBINAR
OCTOBER 6, 2022 at 1:00PM ET / 10:00AM PT

Extending IEC 62304’s Software Lifecycle Principles to Electrical and Mechanical in Medical Device Design

IEC 62304 started out as a functional safety standard, but since its release in 2006, it has become the standard for process life cycle for software. This includes safety classification and has a relationship to other medical device standards like ISO 13485, ISO 14971, IEC 60601 and IEC 63266.

It provides principles of what needs to be done as part of medical device software for technical and management roles and aspects.

In this free, in-depth webinar, Satyajit ‘Sat' Ketkar will explain how these principles can and should be applied to all functions of a medical device, specifically electrical and mechanical life cycles, to provide consistency for process elements like Requirements, Risk Analysis, Failure Mode Analysis Architecture, Design, Implementation, Test, Traceability as well as consistency in language, i.e Items, Units.

Participants will learn how to apply these principles to the entire medical device life cycle, leading to more efficient design, development and manufacturing.

Register for this free webinar, which will provide consistent guidance to all engineers and a better mechanism of planning for the project managers.

Register for the webinar
Velentium-GG Webinar 10-6-22-1
Specifically, this webinar will cover:
  • What is IEC 62304 and why is it important? 
  • How can IEC 62304 be translated, extended and applied to electrical and mechanical life cycles? 
  • What are the basic/first principles and common elements of IEC 62304?
  • How to adopt these principles from IEC 62304 and extend to the entire product life cycle.
Who should attend?
Functional and Project Managers and Technical and Process Engineers. Register Now  

Hosted by

Satyajit ‘Sat Ketkar
Presenter: Satyajit ‘Sat' Ketkar

Technical Director of System Engineering,
Velentium LLC
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Moderator: Etienne Nichols

Medical Device Guru & Community Manager, Greenlight Guru

 

Velentium

About Velentium LLC

Velentium is a professional engineering firm specializing in the end-to-end design, development, and manufacturing of therapeutic and diagnostic active medical devices. End-to-End Medical Device design, development and manufacturing. napkin to post-market including manufacturing. regulations, standards and process involved. 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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