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What Does a Risk-Based QMS Mean? - Featured Image

What Does a Risk-Based QMS Mean?

By Jon Speer on October 1, 2017
What exactly is a risk-based QMS?
How to Switch to eQMS Software When You're Just Using Paper - Featured Image

How to Switch to eQMS Software When You're Just Using Paper

By Jon Speer on September 11, 2017
How reliable is your paper-based quality management system? This situation plays out in medical devi...
How Process Excellence Leads to Product Excellence - Featured Image

How Process Excellence Leads to Product Excellence

By Nick Tippmann on August 2, 2017
Today, we are talking to Mike Fisher, who is the director of product development at the Global Cente...
13 Common Pitfalls to Avoid During Medical Device Product Development - Featured Image

13 Common Pitfalls to Avoid During Medical Device Product Development

By Jon Speer on July 9, 2017
Are you falling into some of the common traps that surround medical device product development?
5 Tips for Conducting Medical Device Management Reviews - Featured Image

5 Tips for Conducting Medical Device Management Reviews

By Jon Speer on June 23, 2017
When was your last company management review? If you’re left scratching your head, it either may not...
CAPA: When to Take Corrective Action or Preventive Action? - Featured Image

CAPA: When to Take Corrective Action or Preventive Action?

By Jon Speer on April 25, 2017
How many of you can confidently initiate a CAPA and know exactly how and what to do and the process ...
Tips for Conducting Better Root Cause Analysis for Medical Device Companies - Featured Image

Tips for Conducting Better Root Cause Analysis for Medical Device Companies

By Jon Speer on April 10, 2017
At some point, every medical device development company will encounter an issue that requires an inv...
How SimplicityMD Is Leveraging Technology Plus a Lean Approach to Help Get Their Devices to Market Faster - Featured Image

How SimplicityMD Is Leveraging Technology Plus a Lean Approach to Help Get Their Devices to Market Faster

By Nick Tippmann on March 29, 2017
In today’s episode we continue our series on new breed medical device company stories. We talk with ...
Key Actions for Effective Customer Complaint Handling - Featured Image

Key Actions for Effective Customer Complaint Handling

By Jon Speer on March 14, 2017
Let's say, your medical device business has received a complaint from a customer.
How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance - Featured Image

How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance

By Nick Tippmann on March 2, 2017
At greenlight.guru, we would like to continue our series on the new breed of medical device companie...
9 Keys to Enacting CAPA for Medical Devices Following Your Internal Audit - Featured Image

9 Keys to Enacting CAPA for Medical Devices Following Your Internal Audit

By Jon Speer on February 28, 2017
Most of us really don’t get excited by the prospect of any kind of audit. The procedures, the paperw...
4 Key Compliance Issues for Medical Device Companies - Featured Image

4 Key Compliance Issues for Medical Device Companies

By Jon Speer on February 11, 2017
The goal for most creators of new medical devices is to be able to get them to market as quickly as ...

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