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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 and we’ll tell you how on this July 17 webinar: http://medgroup.biz/greenlight

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.

Jon Speer, one of our most sought-after presenters and founder of greenlight.guru will speak. He’ll explain how innovative medical device manufacturers are leveraging modern QMS Software to:

• Accelerate product development efforts — from napkin idea, to 510K approval to market release months or years quicker

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

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

• Understand and stay ahead of the FDA and EU changing quality regulations as leaders instead of followers

Our last webinar with Jon was oversubscribed so save your seat today: http://medgroup.biz/greenlight

We’ll send the replay and slides to all who register.

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Speaking of webinars, we have:

• One today about managing regulatory standards in multiple jurisdictions: http://medgroup.biz/standards

• One in a week about how to use the Global Data Synchronization Network to get more business: http://medgroup.biz/GDSN
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Joe Hage
Medical Devices Group Leader

P.S. I’ll be in NY for MD&M East next week. Email me at JHage@MedicalDevicesGroup.net if you’d like to meet.

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Jon Speer
Founder of Greenlight Guru – Helping medical devices get to market faster with less risk
Anil Bhalani Thanks for sharing your comments. I tend to agree with your sentiments.

That’s why I founded greenlight.guru. A modern eQMS designed specifically for medical device professionals.

In fact, we have designed med device specific workflows to easily manage must have design controls and ISO 14971 risk management.

And no, I’m no eQMS software salesman. I’m a nearly 20 year medical device industry veteran who has experience as a product development engineer, regulatory specialist, and quality manager.

I would love a chance to chat with you and pick your brain. Send me a note or send me an email (jon.speer@greenlight.guru).

Anil Bhalani
Consultant – Regulatory Affairs/Quality Assurance
This is exactly what QMS software salesman tell us but is totally wrong. Don’t get me wrong, I tell companies to get QMS software but not for this reason. The advantage of QMS software are electronic archiving and retrieval and all the benefits of managing and sharing documents. Not speed to market. Not compliance with flying colors (in fact I have queried QMS software to see have many reviewers read the document before approving it and found that many did not even open it).

QMS software don’t improve or speed up the design process nor improve compliance since the design is done in a modern AutoCAD software and transferred to QMS software in 2D black and white pdf and reviewed within the QMS software or in print by many computer savvy. Advantage: Save paper. Disadvantage: You loose AutoCAD’s many 3D design features on transfer to QMS software on 2D pdf documents. Then it is just a fancy “electronic paper document” delinked from the AutoCAD software.