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

FDA Pulse Check: September 2019

By: Nick Schofield
October 15th, 2019

FDA released a number of important updates in September 2019, spanning from their premarket submission pathways to integral policy updates. Here are a few of the important highlights from the month.

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Thought Leadership | Industry Updates

What Do You Need to Comply with the EU MDR Postmarket Requirements?

By: Nick Schofield
September 12th, 2019

The deadline for the official implementation of the EU Medical Device Regulation (MDR) is approaching. By May 2020, your medical device organization must be in compliance with many new requirements for your product throughout its life cycle. With this increased focus on the total product life cycle comes an expanded suite of regulations for postmarket surveillance you must be in compliance with. There is a lot to unpack in this aspect of EU MDR, but there are some major compliance areas your organization should be putting in place now.

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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: August 2019

By: Nick Schofield
September 4th, 2019

It’s been quite a summer for FDA. Between a number of recalls, product approvals, releases of consumer information, and updates to key agency programs, there’s a lot to catch up on. Here are a few of the highlights we think are worth keeping an eye on.

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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.

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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.

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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.

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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.

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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.

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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.

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