Medical Device and Pharmaceutical Product Development and Compliance

Cognition Blog

Our blog navigates product development and compliance for the life science industry. Our solutions save time and money, delivering products with less risk.

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cockpit | Medical Device | Compass | Change Management

No Room for Error: The Importance of Managing Change

By: Dale Gallaher
October 19th, 2021

“The Only Constant in Life Is Change.”- Heraclitus Managing information goes straight to the heart of managing change. Why? Because without a rationale, checks and balances, evidence, and assurance of safety, information change – if left unchecked – can potentially lead to hazardous situations. This is especially critical in the intensely regulated medical device industry.

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Medical Device | Product Development | Risk | Risk Management

Three Key Questions for Assessing Medical Device Risk Management Tools

By: David M. Cronin
September 28th, 2021

In the highly regulated world of medical device manufacturing, the relentless requirement to minimize and mitigate risk places a huge onus on design, development, and manufacturing teams. That’s why companies, large and small, are looking for software solutions to help ensure consistency and objectivity in the creation, auditing, and monitoring of critical risk management processes.

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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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Medical Device | Product Development | reusability

Reusability: Data Duplication to Accelerate Medical Device Development

By: Bradley Sylvestre
September 14th, 2021

Key takeaway: The ability to reuse product data can dramatically reduce the time taken to design, gain regulatory approvals, and ultimately bring new medical devices to market. Time equates to money in any business, and in the world of medical device design and manufacturing, that can mean BIG numbers! Depending on the route taken, following FDA regulations, the average cost to bring a medical device to market through the Premarket Approval pathway is $94 million. The less intensive 510(k) process averages out at $31 million.

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design controls | Medical Device | Product Development | Risk | Risk Management

Beyond Excel, Managing Risk in Medical Device Development

By: David M. Cronin
August 17th, 2021

Using unstructured tools such as Word and Excel when doing risk management for medical devices could result in harm to a patient. Why? Because many medical devices are complex, with hundreds to thousands of inter-related design inputs/outputs, testing, and risk management data. Managing that amount of data manually is nearly impossible when using tools like Word and Excel...

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Top 3 Reasons Med Device Should Invest in Structured Data | Cognition

By: Gerald Wesel
April 21st, 2021

The delicate balance between investing and cost-saving at a venture-backed startup or SME is challenging. Particularly at pre-revenue, the CEO and leadership team must steward the capital responsibly and make tough decisions about where to invest – decisions that affect the company’s survival and success.

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cockpit | Cognition News

Cockpit 10 Release: Feature Roundup | Cognition Corporation

By: Cognition Corporation
February 15th, 2021

Giving customers more time to focus on developing great products.  If you are part of a product development team, you know how tedious and time-consuming documentation can be to manage in various word or excel files. We set out to solve that problem over 10 years ago when we launched our solution, Cockpit.  Our goal was to provide a unified and scalable environment to enable companies to structure data and automate processes for more efficient and accurate product development.

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design controls | Compass | 21 CFR 820.30 | EU MDR

Best Practices for a Quality System Based Design Process

By: Sally Carter
January 27th, 2021

Imagine developing a medical device or drug that could be claimed to work without any evidence….

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Medical Device | Product Development

Accelerate Medical Device Development with Systems Engineering

By: David M. Cronin
October 16th, 2020

Systems engineering should be used more often in medical device product development. This may be a strong statement, but it can be transformative for device development through decreased development costs, streamlining of interactions with the FDA, and reduced time-to-market. We would like to address this through a series of articles on systems engineering role in Medical Device Product Development of which this is the first.

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requirements | design controls | 21 CFR 820.30

The Importance of Linking User Needs with Design Requirements

By: Sally Carter
October 1st, 2020

There are many inputs to consider when designing a new medical device product: user needs, regulatory requirements, and internal and external customer requirements, to name a few. Finding harmony and documenting everything is not a simple paperwork exercise. This can be overwhelming to even the most seasoned medical device professional. How do you make sure the user needs are linked to actionable requirements, and ensure that all requirements have been addressed?

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