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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requirements | design controls | Design | Compass MED | Contract Manufacturers

Six Reasons MedTech Contract Design Firms Thrive with Cognition's Compass® MED

By: Patrick Maxwell
January 13th, 2025

In today's rapidly evolving medical device industry, more companies and entrepreneurs are turning to contract design and manufacturing firms to bring their ideas to life. Managing multiple products, teams, and clients simultaneously is nothing new for these firms; however, the increasing complexity of products and immense pressure on time to market demands a more robust approach. That's where a centralized, structured data management and design control solution purpose-built for MedTech such as Compass® MED becomes essential, enabling firms to efficiently organize and analyze the multiple streams of information involved. Here are six key benefits of using Compass MED:

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Blog Feature

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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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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