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

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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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

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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Industry Updates

Best Online Resources for Life Science Industry News

By: Cognition Corporation
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

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

By: Cognition Corporation
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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