Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

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

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?

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

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

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

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

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

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

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 ...

What is CAPA in the Medical Device Industry?

By Jon Speer on February 6, 2017

If you’re relatively new to the medical device development industry, you will have worked out fairly...

How Phagenesis Is Developing a Treatment for Dysphagia with Rebecca Sheridan

By Nick Tippmann on January 12, 2017

What if regulatory affairs were not only viewed as a necessary burden, but actually help a medical d...

How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

By Nick Tippmann on November 8, 2016

Zebra Medical Technologies is part of a new breed of medical device companies. They understand the r...

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