Medical Device Product Development

Navigating Medical Device Design Control & Risk Management

Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.

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Thought Leadership | Industry Updates

7 Takeaways from FDA’s “Clinical Data in Med Device Submissions” Guidance

By: Nick Schofield
March 12th, 2019

After February 21, 2019, new FDA requirements for clinical investigations went into effect. These requirements are intended to ensure clinical data quality and integrity, as well as to protect human subjects’ well-being and safety. As a way of keeping domestic and international premarket medical device submissions consistent for regulatory review, the new acceptance criteria take aim at very particular issues in the compliance process for clinical investigations.

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Thought Leadership | Industry Updates

FDA Pulse Check: February 2019

By: Nick Schofield
February 28th, 2019

FDA was very busy in February 2019. In our latest edition of our FDA Pulse Check series, we’ve highlighted some of the month’s key stories worth catching up on.

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How to Approach Usability Engineering & Use Error Analysis

Learn how activities like Use Error Analysis can lead to more dynamic, impactful risk management.

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Thought Leadership | Industry Updates

FDA Pulse Check: January 2019

By: Nick Schofield
January 29th, 2019

While this was a slower month than usual due to the government shutdown, FDA has still been active. Here are a few important updates from January 2019 your life science organization may want to keep up with.

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Thought Leadership | Industry Updates

FDA Pulse Check: 2018 in Review

By: Nick Schofield
January 10th, 2019

No doubt: 2018 was an important—and extremely busy—year for FDA. Between engaging with the 21st Century Cures Act and applying critical updates to long-standing programs, the agency has spent the past year working hard to position itself well in the changing landscape of life science industries. While there’s a lot worth discussing about the regulatory year that was 2018, a few important milestones are worth a second look.

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Thought Leadership | Industry Updates

FDA Pulse Check: December 2018

By: Nick Schofield
January 2nd, 2019

The year has drawn to a close, but FDA is not slowing down its pace. December 2018 was a big month for the agency, and there’s a lot to talk about. Here are a few important updates to catch up on as we prepare to move into the new year.

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Thought Leadership | Industry Updates

4 FDA Trends Medical Device Manufacturers Should Watch in 2019

By: Nick Schofield
December 13th, 2018

For FDA, 2018 was a busy year; the agency began a number of new initiatives, released a plethora of new draft guidance, and took major steps toward greater collaboration among themselves, industry, and other agencies. In the coming year, expect these efforts to keep going and important new initiatives to take flight. In preparing for these regulatory actions, there are four main trends to watch out for.

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Thought Leadership | Industry Updates

FDA Pulse Check: November 2018

By: Nick Schofield
December 4th, 2018

As the end of 2018 approaches, FDA is busy getting the last of this year’s regulatory activities wrapped up. Here are a few highlights of what they were up to in November.

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Thought Leadership | Industry Updates

FDA Pulse Check: October 2018

By: Nick Schofield
October 30th, 2018

We’re getting close to the end of the year, and FDA is still working at a solid pace. Here are some of the interesting updates in October 2018 we think are worth checking out.

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Thought Leadership | Industry Updates

FDA’s Proposed 2019 Draft Guidance: What Could it Mean for Your Medical Device Organization?

By: Nick Schofield
October 11th, 2018

Next year is shaping up to be big for FDA. Continued initiatives for digital health innovation, industry collaboration, and improving premarket submission processes are going to influence many regulatory actions in 2019. FDA has anticipated this by putting out a list of proposed guidance for development in 2019. The list lacks details on what any new guidance will look like, however. Exploring what’s been proposed, while not definitive, can give your medical device organization a better sense of what FDA might be up to in the coming year.

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