Navigating Product Development and Compliance
Helping to navigate product development and compliance for the life science industry. Our SaaS-based solutions enable customers to structure their data and automate compliance processes with built-in quality templates and automated generation of deliverables to save time and money, delivering their products to market faster with less risk.
Medical Device | Risk | Risk Management | ISO | FMEA
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 | Research & Development | Risk Management | Usability
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.
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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.
Thought Leadership | Risk Management
By:
Cognition Corporation
April 4th, 2019
The Cognition blog had a very busy 2018, and it was all thanks to readers like you. We discussed many pressing topics in life science industries, the latest FDA updates, things happening at Cognition, and so on. In reviewing blog performance in 2018, we found a number of blogs related to risk management that were very popular with our readers, and we wanted to share that list with you.
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