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.

Bradley Sylvestre

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 | reusability

Reusability: Data Duplication to Accelerate Medical Device Development

By: Bradley Sylvestre
September 14th, 2021

Key takeaway: The ability to reuse product data can dramatically reduce the time taken to design, gain regulatory approvals, and ultimately bring new medical devices to market. Time equates to money in any business, and in the world of medical device design and manufacturing, that can mean BIG numbers! Depending on the route taken, following FDA regulations, the average cost to bring a medical device to market through the Premarket Approval pathway is $94 million. The less intensive 510(k) process averages out at $31 million.

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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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