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

How to Tell if Your Life Science Organization Needs Compliance Software Tools

By: Nick Schofield
August 8th, 2019

Does your life science organization need to adopt a compliance software tool?

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Cognition News | NAVIGATE

NAVIGATE2019: An Early Preview of Key Talks and Presentations

By: Alex Critch
August 6th, 2019

NAVIGATE2019 is coming up September 5-6 at the Marriott Long Wharf Hotel in Boston, Massachusetts. We’re excited for the incredible lineup of talks and presentations this year, and we hope you’ll join us. If you’re curious about what you’ll see and learn about this year, then you’re in luck! Here’s a preview of just a few of this year’s presentations.

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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

7 Reasons to Consider Adopting Compliance Software Tools

By: Nick Schofield
August 1st, 2019

Many organizations tend to stick with what’s worked for them in the past for regulatory compliance due to its complexities and the need to assure that new products are safe and effective. This is especially true when it comes to compliance activities such as design controls. While this attitude is understandable, it does present some problems. It can limit an organization’s ability to remain competitive in the market, and it can also impede long-term business growth.

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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

6 Quick Facts about FDA’s Medical Device Development Tools Program

By: Nick Schofield
July 25th, 2019

In July 2019, Ed Margerrison and Hilda Scharen of CDRH released information on FDA Voices about how the agency is working to increase the pace of medical device innovation. By using sound science and proven methodologies, FDA plans to work with device manufacturers to get beneficial products to market faster.

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Thought Leadership

Correcting 6 Common Misunderstandings About FDA’s Design Controls Regulation

By: Nick Schofield
July 23rd, 2019

FDA’s Design Controls regulation can be an open book but sometimes hard to read. Interpretations of the various regulatory requirements contained within 21 CFR 820.30 can vary both between and within life science organizations. The challenge becomes interpreting the requirements and implementing them into your development processes in such a way that does not negatively impact product quality or your larger quality system.

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Thought Leadership

5 Questions to Ask After Completing Design Reviews

By: Nick Schofield
July 18th, 2019

FDA’s Design Controls regulation has no clear mandate as to the purpose of design reviews. Rather, they are concerned with seeing evidence these reviews are conducted at regular intervals by appropriate parties. Determining what data comes out of a design review is ultimately up to your organization’s needs and objectives.

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Thought Leadership

Why Take the Compliance-First Approach in Life Science Product Development?

By: Nick Schofield
July 16th, 2019

Compliance from the start—why make it a priority in life science product development?

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Thought Leadership

3 Reasons to Worry about FDA Form 483s for Design Controls

By: Nick Schofield
July 11th, 2019

In life science industries, many believe that regulatory inspections are focused more on postmarket activities. This attitude isn’t surprising; however, its results can be detrimental. Many companies elect to focus on bolstering their postmarket compliance, allowing other regulatory activities such as design controls to lapse or deteriorate over time. Unfortunately for these companies, the truth about regulatory inspections is starkly different than their beliefs, and that can come back to haunt them.

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