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.

David M. Cronin

Blog Feature

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.

Read More

Share

Blog Feature

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...

Read More

Share

How to Approach Usability Engineering & Use Error Analysis

Learn how activities like Use Error Analysis can lead to more dynamic, impactful risk management.

Subscribe to the blog and get this guide for free

Blog Feature

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.

Read More

Share