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.
Medical Device | Risk Management | Compass | Design | compliance | Regulations
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.
Medical Device | Risk Management | Compass | Design | compliance | Regulations
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
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.
Medical Device | Risk Management | Compass | Design | compliance | Regulations
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.
Medical Device | Risk Management | Compass | Design | compliance | Regulations
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.
Medical Device | Risk Management | Compass | Design | compliance | Regulations
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:
cockpit | Medical Device | Compass | Change Management
By:
Dale Gallaher
October 19th, 2021
“The Only Constant in Life Is Change.”- Heraclitus Managing information goes straight to the heart of managing change. Why? Because without a rationale, checks and balances, evidence, and assurance of safety, information change – if left unchecked – can potentially lead to hazardous situations. This is especially critical in the intensely regulated medical device industry.
design controls | Compass | 21 CFR 820.30 | EU MDR
By:
Sally Carter
January 27th, 2021
Imagine developing a medical device or drug that could be claimed to work without any evidence….
Medical Device | Product Development | Compass
By:
Ansgar Liening
August 27th, 2020
Often in medical device product development, functions exist in silos. Risk, requirements, and test management functions often exist separately, on their own - different systems, different teams, different objectives. Yet, the data related to these functions are both continuously changing and highly dependent on one another. Some type of process is needed to (1) manage the effect of changes across all three systems and (2) provide evidence of a process for notified bodies if and when needed.
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