How To Become a True Medical Device Quality Professional

How To Become a True Medical Device Quality Professional

3 min reading time

Reading Time: 3 minutes

I was talking to Jon Speer from Greenlight Guru about how to become a true quality professional.

He shared, “I have a choice and the choice is purely up to me. I can choose to be status quo and be a checkboxer or I can elevate my game and focus on becoming a true quality professional.” Here’s a short video of our conversation.

Jon is giving a two-hour workshop, “How to Implement a Risk-based QMS to Comply with 13485 Leveraging ISO 14971,” April 3rd, 2018 at the Meadowlands. You can get the brochure on our homepage.

Joe Hage: Hey, it’s Joe. I’m here with Jon Speer from Greenlight Guru. Hey Jon. Jon, you talked about a checkbox mentality. What exactly does that mean and what’s the alternative?

Jon Speer: A checkbox mentality is somebody who’s just going through the motions.

They’re just trying to check a box and make sure that they’ve satisfied what the regulatory bodies, the ISO auditing groups, FDA, what they think that they want. So, they’re not really interested in what the content is or what the process is, they just want to check the box.

A true quality professional is someone that rises above just checking a box on the form and understands why these changes are important especially for the patients who are going to receive our medical products.

Joe Hage: Thank you, Jon. What does the EU MDR look like for a checkboxer versus a true quality professional?

Jon Speer: I want to start with the true quality professional: Let’s give people the best possible outcome of shifting their mindset and the true quality professional gets ahead of the situation.

They don’t wait for it to happen to them and with the changes in EU MDR; the checkboxer is gonna wait.

The true quality professional is being proactive. They’re reaching out to the notified bodies. They’re intimately involved in trying to understand what is changing about the regulations in Europe and how that impacts our products and they’re trying to make sure that they understand not only what the regulatory bodies need but also what is important to the patient.

Now the checkboxer, maybe not so much. They’re not putting any value in it and the thing about that is, when you take that approach, a year from now you’re going to have to update your technical files, the documentation that’s important for the EU CE mark process, which is a big part of these MDR changes.

If you just check the box and you got no value out of that you’re going to go through that step again, you’re just going to check a box again and again and again. You’re going to get burnout as a medical device professional and your products aren’t going to improve.

Joe Hage: Great answer thank you. How can Greenlight Guru help the true quality professional?

Jon Speer: I care very much about patients. I believe wholeheartedly that the reason I’m here on this earth is to help improve the quality of life and that could be through a number of ways.

What we’ve done at Greenlight is we’re helping the medical device professional, the true quality professional, because we built a software platform, an eQMS software platform, that addresses compliance, because you still have to deal with the compliance, but we’ve taken the guesswork out of the equation for the true quality professional.

Now, the content, the information they capture, that they document, in Greenlight’s “Go-and-Grow” products is a single source of truth that allows them to make better-informed decisions about ways to improve their products, that allows them to make better-informed decisions about ways to improve their products, their processes, their technologies so that, in the end, the patient’s life will be impacted for the better.

Joe Hage: You are consistently one of our highest-rated speakers. I will see you at MDTX, and… Give me a high five!

This broadcast was brought to you by MDTX, the Medical Device Technology Exchange. Meet me and Jon Speer at MDTX, April 3-5 in Secaucus, New Jersey, at the Meadowlands where Jon will present “How to Implement a Risk-based QMS to Comply with 13485 Leveraging ISO 14971,” a two-hour workshop, April 3rd at the Meadowlands.

See you there!