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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design controls | Testimonial | Compass MED | Traces

Compass MED and Kimberly-Clark: A Customer’s Perspective On the Impact and Benefits

By: Cognition Corporation
September 26th, 2024

At Cognition, the success of our customers is key. That’s why our latest product, Compass MED, was designed with 3 key priorities in mind: Improve efficiencies, incorporate quality by design, and enhance risk management and compliance.

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Medical Device | Risk Management | Compass | Design | compliance | Regulations

Seven Ways Compass MED Helps Speed Time to Market for Med Device Manufacturers

By: Ben Higgitt
September 10th, 2024

Medical device manufacturers face significant pressures to bring safer products to market faster. However, meeting critical project milestones and launch dates on time and within budget is becoming increasingly difficult. Medical devices are becoming more complex—which makes product development more difficult. At the same time, industry standards and regulations are evolving, placing new pressures on quality, regulatory, and engineering teams.

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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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Medical Device | Risk Management | Compass | Design | compliance | Regulations

Panel Discussion: 3 Industry Leaders Explore How Medical Device Manufacturers Can Speed Time to Market

By: Cognition Corporation
August 5th, 2024

How can medical device manufacturers successfully balance the significant pressures of today’s market? On the one hand, they need to bring new devices to market quickly. On the other hand, devices are becoming much more complex, while at the same time, industry standards and regulations are continuing to evolve. During our recent webinar, three panelists—Nathan Brown, R&D Fellow at Boston Scientific; Mike Casper, System Engineer Manager at Smith & Nephew; and Eric Maas, a former Medtronic executive and founder of Six Sigma Experts—shared their perspectives on how medical device manufacturers can achieve speed to market, safely.

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Medical Device | Risk Management | Compass | Design | compliance | Regulations

Are You Leading or Falling Behind? How Innovative Medical Device Manufacturers are Modifying Their Design Control Process

By: Gerald Wesel
April 22nd, 2024

Most medical device manufacturers continue to rely on manual and Word/Excel-based approaches for design control and risk management—and that’s hindering their ability to achieve critical strategic initiatives, including improving efficiency and accelerating time to market.

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Medical Device | Risk Management | Compass | Design | compliance | Regulations

How to Speed Time to Market: Our CEO’s Take on Emerging Challenges and Acceleration Opportunities for Medical Device Companies

By: Cognition Corporation
March 19th, 2024

A Q&A With Gerald Wesel, Cognition Chairman and CEO Gerald Wesel, Cognition’s Chairman and CEO, is responsible for setting the company’s strategic direction. He is known for propelling innovative, disruptive technology companies to next level success, and has previously served in leadership roles at seven startups and four large enterprises. In this Q&A, he provides his take on how medical device development is evolving—and the persistent and emerging challenges that device companies are facing as a result. He also shares some key strategies that device company leaders should be employing to help their organizations adapt and thrive.

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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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Medical Device | Risk Management | Compass | Design | compliance | Regulations

Rising Risk: Why Many Medical Device Companies Are In Danger of Risk Analysis Missteps

By: Ben Higgitt
January 9th, 2024

Risk analysis is crucial for ensuring safety and efficacy, but a recent survey of 100 medical device development and quality leaders revealed that many lack confidence in their current risk analysis processes.

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Medical Device | Risk Management | Compass | Design | compliance | Regulations

How Medical Device Companies Can Leverage Real-Time Traceability to Speed Up Development, Increase Accuracy

By: Dale Gallaher
December 18th, 2023

When it comes to medical device development, efficiency, speed, and accuracy are gamechangers. The faster you can move without sacrificing safety or quality, the quicker your time to market and the sooner your impact on patient care.

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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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