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Product Development

eIFU Requirements: Everything You Need to Know About Electronic Instructions for Use

May 11, 2023
It doesn’t matter how well-engineered or high-quality your medical device is; you still need to make sure people know how to use it. Read More
Product Development

Planning Your Medical Device Global Market Regulatory Strategy

May 5, 2023
A regulatory strategy is more than just picking a pathway to market. It’s an in-depth process by which you choose the best markets and pathways not only for your device, but... Read More
Product Development

3 Things to Love about Internal Audits

April 28, 2023
I have a confession to make—I love audits. I mean, I really love audits. Read More
Product Development

4 Advantages of an eQMS Over a Paper-Based QMS

April 21, 2023
One of the biggest factors that determines a medical device company’s success is how effectively they manage quality processes. Read More
Product Development

5 Tips for Running Effective Internal Quality Audits

March 31, 2023
How did your last internal quality audit go? Internal audits can be a bit of a scramble for some medical device companies. Read More
Product Development

Beginner's Guide to Design Verification & Design Validation for Medical Devices

February 10, 2023
Design verification and design validation are two essential stages in design controls. It’s easy to confuse the two because they both involve checking an outcome against your... Read More
Product Development

3 Types of QMS Audits (Plus 3 Tips to Prepare for Them)

January 15, 2023
The purpose of a QMS audit is to ensure your company has established the appropriate processes and procedures within your quality management system (QMS), and that those... Read More
Establishing a QMS

Tips for Structuring Your Internal Audit Program (and Mistakes to Avoid)

January 1, 2023
After a refreshing holiday break, there’s one question you need to ask yourself as you head into the new year: Do we have a plan in place for internal auditing this year? Read More
Product Development

The Best of Jon & Mike Through the Years

December 28, 2022
Today’s episode is a little different than usual. This will be Jon Speer’s last podcast for Greenlight Guru, as he’ll be moving on to future ventures as of December 31st. Read More

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