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.

Blog Feature

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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Blog Feature

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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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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