Medical Device and Pharmaceutical Product Development and Compliance

Navigating Product Development and Compliance

Helping to navigate product development and compliance for the life science industry. Our SaaS-based solutions enable customers to structure their data and automate compliance processes with built-in quality templates and automated generation of deliverables to save time and money, delivering their products to market faster with less risk.

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Thought Leadership | Industry Updates | Regulatory Compliance

How to Plan Ahead for the EU MDR Transition

By: Cognition Corporation
November 7th, 2019

By May 2020, the new European Union Medical Device Regulation (EU MDR) will be fully implemented. Medical device manufacturers now need to comply with a set of new and critically important regulations. While this deadline is fast arriving, there is still time to plan ahead. To make that planning as effective as possible, there are several key approaches your organization should think about taking.

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Thought Leadership | Industry Updates

FDA Pulse Check: October 2019

By: Cognition Corporation
October 31st, 2019

October 2019 was a very productive month for FDA. As it draws to a close, let’s take a look at some of the important highlights in this month’s FDA Pulse Check.

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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: September 2019

By: Cognition Corporation
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: Cognition Corporation
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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Thought Leadership | Industry Updates

FDA Pulse Check: August 2019

By: Cognition Corporation
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: Cognition Corporation
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: Cognition Corporation
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: Cognition Corporation
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: Cognition Corporation
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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