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4 Emerging Trends in 2020 Backed by Medical Device Industry Experts - Featured Image

4 Emerging Trends in 2020 Backed by Medical Device Industry Experts

Throughout 2020, the medical device industry will see significant changes take flight. Among the big...
[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD) - Featured Image

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

In this modern digital world, did you know that most medical devices are not connected to the Intern...
Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now - Featured Image

Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now

With the deadline for compliance with the EU MDR just around the corner, big changes are being made ...
How to Leverage IEC 62304 to improve SaMD Development Processes - Featured Image

How to Leverage IEC 62304 to improve SaMD Development Processes

How can the IEC 62304 standard serve as a framework for your Software as a Medical Device (SaMD) dev...
What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process? - Featured Image

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

The FDA announced another new pilot program to improve the consistency and efficiency of its 510(k) ...
How to Choose the Right FDA Regulatory Pathway for your Device - Featured Image

How to Choose the Right FDA Regulatory Pathway for your Device

Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k...
The Definitive Guide to ISO 14971 Risk Management for Medical Devices - Featured Image

The Definitive Guide to ISO 14971 Risk Management for Medical Devices

FDA Form 483 Observations and Warning Letters - What’s the Difference? - Featured Image

FDA Form 483 Observations and Warning Letters - What’s the Difference?

If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...
7 FDA Pathways to Bring Your Medical Device to Market - Featured Image

7 FDA Pathways to Bring Your Medical Device to Market

Anyone reading this who is planning to launch a medical device in the U.S. has likely heard of the 5...
Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets) - Featured Image

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

As leaders of medical device companies, our goal is always to create devices that are safe and effec...
4 Major Reasons to Use Document Version Control Software for your Medical Device - Featured Image

4 Major Reasons to Use Document Version Control Software for your Medical Device

With the incredible volume of documentation required by the FDA and ISO, using a document control sy...
7 Tips to Comply With FDA 21 CFR Part 11 - Featured Image

7 Tips to Comply With FDA 21 CFR Part 11

When it comes to regulatory compliance for medical device companies, there can be some confusion aro...

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