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.

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Thought Leadership

3 Commonly Cited Design Controls in FDA Form 483s

By: Nick Schofield
November 14th, 2019

FDA Form 483 Inspectional Observations are one of the many tools the agency uses to verify medical device products do not expose users and patients to undue risk. Many of the commonly cited observations involve some aspect of design controls regulations, which is of particular concern for development teams and manufacturers. Of the 438 inspectional observations in FY2017, FDA cited three design controls regulations more commonly than all others:

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Thought Leadership

4 Reasons Your Life Science Organization Should Adopt Compliance Software

By: Nick Schofield
November 12th, 2019

Deciding to adopt a compliance software tool is not always a straightforward process. There are a number of aspects that need to be addressed—potential quality system issues, user adoption, and so on. Despite these concerns, however, there are some clear benefits to software adoption that should be taken into account. From improving documentation to establishing greater accountability, there are four distinct reasons to consider adopting compliance software.

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How to Approach Usability Engineering & Use Error Analysis

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

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Thought Leadership | Industry Updates | Regulatory Compliance

How to Plan Ahead for the EU MDR Transition

By: Nick Schofield
November 7th, 2019

By May 2020, the new European Union Medical Device Regulation (EU MDR) will be fully implemented. Medical device manufacturers now need to comply with a set of new and critically important regulations. While this deadline is fast arriving, there is still time to plan ahead. To make that planning as effective as possible, there are several key approaches your organization should think about taking.

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cockpit | Thought Leadership

3 Reasons Why People Choose the Cockpit® Platform

By: Alex Critch
November 5th, 2019

There are many reasons why life science organizations choose the Cognition Cockpit Platform for their design controls and risk management activities. Cockpit’s numerous functionalities and features have been deployed by businesses large and small, and to great success. But what were the deciding factors for those organizations, and do they make sense for you?

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Thought Leadership | Industry Updates

FDA Pulse Check: October 2019

By: Nick Schofield
October 31st, 2019

October 2019 was a very productive month for FDA. As it draws to a close, let’s take a look at some of the important highlights in this month’s FDA Pulse Check.

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design controls | Thought Leadership

6 Questions to Guide Your Design Controls Documentation

By: Nick Schofield
October 29th, 2019

Do you want to improve your design controls documentation? If so, the first step is to evaluate how your current processes and procedures are working and how effective their results are. To work through this process, there are six important questions to ask, ranging from your design outputs and risk management to the current state of your product data across multiple sites. Answering these questions thoroughly and honestly can empower greater levels of design controls compliance in your premarket submission activities.

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Thought Leadership

How to Improve Your Design Controls Documentation

By: Nick Schofield
October 24th, 2019

Generating and managing your compliance documentation for premarket submission takes a lot of time and effort. And when there are inconsistencies or other major issues, especially when it comes to design controls, a number of adverse effects could impact your organization. From time lost to remediation to delays to market, it can seriously cost your life science organization. To combat these issues, you can use a number of tactics to improve your design controls documentation.

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Thought Leadership

4 Steps to Better Internal Auditing in Life Science Product Development

By: Nick Schofield
October 22nd, 2019

Internal auditing is an important activity for life science organizations not just during product development, but through the overall product life cycle as well. It allows your business to self-monitor according to the necessary quality management system (QMS) rules and requirements laid out by FDA and other regulatory bodies. But some organizations might find themselves struggling with this compliance aspect: how do you ensure your internal auditing is up to standard? Here are four steps you can take to improve your auditing capabilities and efficacy.

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Thought Leadership

3 Ways to Improve Your Premarket Submission Documentation

By: Nick Schofield
October 17th, 2019

Submitting your life science product for premarket review is a stressful endeavor; if it is rejected by regulators for insufficient documentation or other issues, it can result in lost time to market and loss of time and resources in remediation. Overcoming those issues is not an easy thing, and knowing what to do is not readily apparent. However, there are three important strategies your organization can use to improve your premarket submission documentation, potentially reducing the likelihood of rejection.

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