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How to Implement and Maintain an Audit-Ready QMS Leveraging Technology

A session by Jon Speer
Founder & VP of QA/RA, Greenlight Guru

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About this talk

Despite ever-changing and increasingly complex medical device regulations, many companies have built their compliance systems on risky paper-based quality systems or legacy, general-purpose software not built for med device. You can do better.

Inefficient systems increase your risk of noncompliance and increase your development time. That translates into missed sales opportunities and patients waiting longer for your new medical technologies.

So we’ll show you a modern, purpose-built software that ensures compliance with all the latest regulations to free up your engineers’ time, reduce risk, time to market, and help you pass audits with flying colors.

• Step-by-step instructions on how to implement and maintain an audit-ready QMS leveraging Jon’s S.M.A.R.T. quality management philosophy

• How to accelerate product development efforts — from napkin idea to 510(k) clearance to market release months or years quicker

• How to manage risk to drive the safety and quality of products and processes through QMS per ISO 13485:2016 & 21 CFR Part 820

• How to change their company’s focus from simply meeting regulations to building quality into their processes as a differentiator

• How to understand and stay ahead of the FDA and EU changing quality regulations as leaders instead of followers

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