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Product Development

Managing Major Changes to Medical Device Packaging

May 29, 2023
Charles Darwin famously said, “It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is most adaptable to change.”... Read More
Product Development

What is a Modern QMS?

May 26, 2023
For medical device companies, the role of the quality management system (QMS) has greatly evolved—in both form and function. Read More
Product Development

4 Tips for Managing Your MedTech Portfolio

May 24, 2023
There’s no doubt that MedTech is a noble industry, built on the mission of improving the quality of life with impactful medical devices. Read More
Product Development

How To Vet Medical Device Distributors in Multiple Markets

May 15, 2023
The majority of medical device companies, even the relatively big ones, will need third-party distributors to get their devices to market. Read More
Product Development

What is the Best Way to Structure a Risk Management File?

May 14, 2023
The medical device risk management process relies heavily on the use of documentation. Whether the activity is conducted onsite or offsite, during design or after... Read More
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

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