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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Medical Device | Risk Management | Compass | Design | compliance | Regulations

How to Identify an Effective Medical Device Design Control Software Platform: 9 Key Considerations

By: Ansgar Liening
February 5th, 2024

Critical software functionality for every medical device development company Medical device development companies are increasingly recognizing the value of a purpose-built medical device design control software platform for delivering safer products to market faster, with less risk and less cost. Robust documentation processes, provided via an effective software platform that supports audits and more, ultimately lead to higher-quality products.

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Medical Device | Risk Management | Compass | Design | compliance | Regulations

Rising Risk: Why Many Medical Device Companies Are In Danger of Risk Analysis Missteps

By: Ben Higgitt
January 9th, 2024

Risk analysis is crucial for ensuring safety and efficacy, but a recent survey of 100 medical device development and quality leaders revealed that many lack confidence in their current risk analysis 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 | Risk Management | Compass | Design | compliance | Regulations

How Medical Device Companies Can Leverage Real-Time Traceability to Speed Up Development, Increase Accuracy

By: Dale Gallaher
December 18th, 2023

When it comes to medical device development, efficiency, speed, and accuracy are gamechangers. The faster you can move without sacrificing safety or quality, the quicker your time to market and the sooner your impact on patient care.

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Medical Device | Risk Management | Compass | Design | compliance | Regulations

Stay Ahead of the Curve: 10 Ways to Achieve Medical Device Compliance

By: Bradley Sylvestre
June 26th, 2023

Save time and money by addressing regulations early and often Medical device engineers are tasked with developing innovative and safe products while meeting a multitude of regulations in an ever-changing landscape. Meeting these regulations can be challenging and expensive, especially for startups and smaller companies. Here are 10 ways to help medical device engineers meet regulations without wasting their design budget or timeline:

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Medical Device | Product Development | Risk Management | Design | Process | Documentation

Cultivating Risk Focused Design Instincts

By: Sally Carter
September 29th, 2022

How a risk-based design approach provides safer and ultimately better quality products to market. Product designs are stronger when risk is inherently considered. Not everyone has the experience and instincts to naturally consider the critical factors required in a comprehensive approach. A solid process ensures risk is addressed consistently throughout product development by all of the stakeholders. It is not enough to intuitively consider risk when designing a product; decisions need to be articulated and documented - this documentation is used to support the design choices throughout the product's life.

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Medical Device | Product Development | Risk Management | Webinar

Webinar On Demand: Why Flexibility and Support Matter for Effective Risk Management

By: David M. Cronin
September 9th, 2022

Medical device development is a complex process, with a critical element focusing on risk management. The consequences of not managing risk properly can be catastrophic.

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design controls | Product Development

Space and Time. Are You Considering the 4th Dimension in Product Development Data?

By: Ansgar Liening
June 15th, 2022

An introduction to how smart data utilizes information and actionable context to support business-critical decisions.

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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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