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.

Ansgar Liening

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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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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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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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Blog Feature

Medical Device | Product Development | Compass

Only a Comprehensive Process Can Deliver True Quality in Medical Device Development

By: Ansgar Liening
August 27th, 2020

Often in medical device product development, functions exist in silos. Risk, requirements, and test management functions often exist separately, on their own - different systems, different teams, different objectives. Yet, the data related to these functions are both continuously changing and highly dependent on one another. Some type of process is needed to (1) manage the effect of changes across all three systems and (2) provide evidence of a process for notified bodies if and when needed.

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