Navigating Medical Device Design Control & Risk Management
Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.
Over the past few years, life science organizations have produced and marketed more products and services intended for mental health treatment. While certainly not a novel effort by the industry, the increased pace reflects cultural, economic, and scientific shifts that are changing the way we view and treat mental illness. For many organizations joining this new wave, the territory is unfamiliar and uncertain. However, there are a few baseline concerns that, once understood, can help development teams push for products meant to treat mental illness.
Coming up with the design inputs for your life science product is not an easy task; your teams need to make sure their scope and applicability are appropriate in relation to the needs of your users and patients. But before you get to that point, you have to first generate the ideas and insights that will become those design inputs. Where do you find this data?
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The 5th Annual INCOSE Systems Engineering (SE) in Healthcare Conference is happening May 1-2, 2019. This conference, hosted in Minneapolis, Minnesota by the INCOSE Healthcare Working Group, features two days of talks, panels, and collaborative experiences for attendees, with a conference theme of "How SE Can Reduce Cost and Improve Quality.” But why attend? Here are five reasons your life science organization’s SE professionals should attend this year’s conference.
The transition between innovation stages and design controls is not simple to manage. It takes a lot of planning, preparation, and diligence to do well. Many life science organizations struggle in moving between these stages, and pinpointing the causes for this can be difficult. When evaluating your organization’s struggle with moving between innovation and design controls, there are four key areas to look at.
March 2019 was a very busy month for FDA, and there’s a lot of news to catch up on. Here are some of the highlights you may want to stay on top of.
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.
What does it take to build a robust risk management program at your life science organization?
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.
In order to lay the foundations of a robust risk management program at your life science organization, many important activities must be undertaken. One particularly critical component worth considering is an iterative approach to risk management.