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.

Blog Feature

Thought Leadership | Industry Updates

FDA Pulse Check: July 2019

By: Nick Schofield
July 30th, 2019

We’re halfway through the regulatory year, and there’s a lot we could cover in the July 2019 edition of the FDA Pulse Check. Here are a handful of important updates we think are worth keeping tabs on.

Read More

Share

Blog Feature

Thought Leadership | Industry Updates

FDA Pulse Check: June 2019

By: Nick Schofield
June 27th, 2019

Things appear to be slowing down at FDA as summer approaches. June 2019 saw less regulatory activity than in previous months, but there are still a handful of important updates worth checking up on.

Read More

Share

How to Approach Usability Engineering & Use Error Analysis

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

Subscribe to the blog and get this guide for free

Blog Feature

Thought Leadership | Industry Updates

A Refresher on FDA Form 483s and Inspectional Observations

By: Nick Schofield
June 18th, 2019

FDA Form 483 inspectional observations can be disruptive to life science organizations, causing anything from delays in time to market to lost profit on currently marketed products. However, it’s vital to tackle the disruption to minimize these issues; procrastinating on or ignoring a 483 only makes the situation worse.

Read More

Share

Blog Feature

Thought Leadership | Industry Updates

FDA Pulse Check: May 2019

By: Nick Schofield
June 4th, 2019

There was a lot happening at FDA during May 2019. As we’ve already discussed on the blog, CDRH’s new Office of Product Evaluation and Quality is now up and running. Besides this big piece of news, there are some other FDA stories worth catching up on this month.

Read More

Share

Blog Feature

Industry Updates

Best Online Resources for Life Science Industry News

By: Alex Critch
May 28th, 2019

The pace at which news travels nowadays makes it difficult to keep up with the latest life science industry trends. However, here are some great resources that we think are worth your attention.

Read More

Share

Blog Feature

Thought Leadership | Industry Updates

FDA Pulse Check: April 2019

By: Nick Schofield
April 30th, 2019

Between a redesign of their website and a number of different actions undertaken related to patient safety concerns, FDA had a lot going on April 2019. Here are a few key highlights of this month.

Read More

Share

Blog Feature

Thought Leadership | Industry Updates

FDA Pulse Check: March 2019

By: Nick Schofield
April 9th, 2019

March 2019 was a very busy month for FDA, and there’s a lot of news to catch up on. Here are some of the highlights you may want to stay on top of.

Read More

Share

Blog Feature

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.

Read More

Share

Blog Feature

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.

Read More

Share