Medical Device Product Development

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.

Blog Feature

Events | Cognition News

6 Must-See Talks at the 2019 INCOSE Healthcare Conference

By: Alex Critch
April 25th, 2019

The 2019 INCOSE Systems Engineering (SE) in Healthcare Conference is quickly approaching, and Cognition is excited to be there this year. The conference is set to be two days of informative talks, networking, and fun for all in attendance. The INCOSE Healthcare Working Group recently released the tentative conference program, and here we’re highlighting six talks for attendees.

Read More

Share

Blog Feature

Thought Leadership

Common Concerns for Developing Life Science Products That Address Mental Health

By: Nick Schofield
April 23rd, 2019

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.

Read More

Share

How to Approach Usability Engineering & Use Error Analysis

Learn how activities like Use Error Analysis can lead to more dynamic, impactful risk management.

Subscribe to the blog and get this guide for free

Blog Feature

Thought Leadership

9 Sources of Design Inputs for Life Science Product Development

By: Nick Schofield
April 18th, 2019

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?

Read More

Share

Blog Feature

Events | Thought Leadership

5 Reasons to Attend the 2019 INCOSE Healthcare Conference

By: Alex Critch
April 16th, 2019

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.

Read More

Share

Blog Feature

Thought Leadership

4 Reasons Your Transition Between Innovation & Design Controls is Struggling

By: Nick Schofield
April 11th, 2019

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.

Read More

Share

Blog Feature

Thought Leadership | Industry Updates

FDA Pulse Check: March 2019

By: Nick Schofield
April 9th, 2019

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.

Read More

Share

Blog Feature

Thought Leadership | Risk Management

Cognition’s 11 Most Popular Risk Management Blog Posts of 2018

By: Alex Critch
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. 

Read More

Share

Blog Feature

Thought Leadership

5 Foundations of Robust Life Science Risk Management Programs

By: Nick Schofield
April 2nd, 2019

What does it take to build a robust risk management program at your life science organization?

Read More

Share

Blog Feature

Thought Leadership

What the Safety and Performance 510(k) Means for Medical Device Manufacturers

By: Nick Schofield
March 28th, 2019

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.

Read More

Share