News from Cognition Corporation
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.
In February 2019, FDA published a final guidance document that expanded parts of its 510(k) premarket notification program. The guidance establishes a new pathway: The Safety and Performance Based 510(k). With this novel premarket pathway comes several new opportunities and benefits to device manufacturers, plus some challenges. Understanding these benefits and challenges together—as well as where the Safety and Performance 510(k) fits in the premarket environment—can help your organization better navigate your device’s path to regulatory submission.
The design and development planning stage can be an exciting time for your life science organization. However, it can also be stressful. Between making sure your teams can handle bringing your product from concept to realization and ensuring both compliance and quality throughout the process, there’s a lot you’ll have to manage. This can be very overwhelming.
Managing the risks of your life science product can be a complex task. Some risks must be assumed, while others need to be controlled, transferred, monitored, or designed out of the product entirely. Implementing risk controls to reduce and manage the impact of associated risks, as well as their probability of occurrence, is the most common approach manufacturers leverage in their design and development efforts.
The FDA Pulse Check is a monthly series of blog posts from Cognition focusing on the latest news, updates, and information from FDA relating to life sciences industries.
FDA was very busy in February 2019. In our latest edition of our FDA Pulse Check series, we’ve highlighted some of the month’s key stories worth catching up on.
The FDA Pulse Check is a monthly series of blog posts from Cognition focusing on the latest news, updates, and information from FDA relating to life sciences industries.
The year has drawn to a close, but FDA is not slowing down its pace. December 2018 was a big month for the agency, and there’s a lot to talk about. Here are a few important updates to catch up on as we prepare to move into the new year.
The FDA Pulse Check is a monthly series of blog posts from Cognition focusing on the latest news, updates, and information from FDA relating to life sciences industries.
The year has drawn to a close, but FDA is not slowing down its pace. December 2018 was a big month for the agency, and there’s a lot to talk about. Here are a few important updates to catch up on as we prepare to move into the new year.
With such a wide market projected for mobile medical apps, one thing is clear—mobility is going to become a key user need for life science products. And even with products that, by design, must remain immobile (such as CT scanners), remote access to the data they generate and retain is a necessity. The world is mobile, and our life science products must shift to meet that world.
Mobility can be a great benefit to life science organizations and their products, but it also presents several challenges, particularly in regard to risk management. Identifying them earlier in the development process makes it easier to evaluate and control them.
