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:
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:
Medical Device | Product Development | Risk Management | Design | Process | Documentation
By:
Sally Carter
September 29th, 2022
How a risk-based design approach provides safer and ultimately better quality products to market. Product designs are stronger when risk is inherently considered. Not everyone has the experience and instincts to naturally consider the critical factors required in a comprehensive approach. A solid process ensures risk is addressed consistently throughout product development by all of the stakeholders. It is not enough to intuitively consider risk when designing a product; decisions need to be articulated and documented - this documentation is used to support the design choices throughout the product's life.
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Medical Device | Product Development | Risk Management | Webinar
By:
David M. Cronin
September 9th, 2022
Medical device development is a complex process, with a critical element focusing on risk management. The consequences of not managing risk properly can be catastrophic.
Medical Device | Product Development | Risk | Risk Management
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.
design controls | Medical Device | Product Development | Risk | Risk Management
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...
Medical Device | Risk | Risk Management
By:
Ben Higgitt
August 11th, 2020
SEPARATE RISK MANAGEMENT AND FMEA FOR BETTER MEDICAL DEVICE DEVELOPMENT. The below is an excerpt of the article originally published on MDDI. FMEA (Failure Mode and Effects Analysis) is utilized to identify potential failure modes in the design or manufacturing of a product. But risks associated with medical devices are not created by failures alone. A product may never fail, but there are still potentially many other risks.
Product Development | Thought Leadership | Risk Management
By:
Cognition Corporation
November 19th, 2019
Your product’s intended patients have a wealth of experience and information that can be valuable to your development process. Whether it’s the day-to-day realities of the condition, the symptoms they feel need the most attention, or things they might be missing in their current treatment regimens, this data cannot be elicited from doctors and engineers alone.
Thought Leadership | Risk Management
By:
Cognition Corporation
May 2nd, 2019
Implementing a robust risk management program into your life science organization requires a solid understanding of your needs, capacities, and goals. Whether to improve alignment with regulatory requirements and standards or adjust your overall risk procedures, identifying what you can do to bolster your current risk management programs is vital to promoting long-term growth. There are many ways out there to improve your risk management, but there are a few worth using as a baseline to build on.
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