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

4 Risk Management Concerns for Mobile Medical Apps

By: Nick Schofield
December 11th, 2018

Mobile medical applications are part of the future in medical devices. More apps are coming online now than ever before; an estimated 200 health-related mobile apps make it to market each day. Their growing presence in healthcare has significant impact, from reductions in healthcare costs, to advancing smarter diagnostics (through leveraging big data analytics and AI), to greater access to care—especially in remote locations.

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Thought Leadership

3 Principles for Better Usability Risk Management

By: Nick Schofield
December 6th, 2018

Usability is important for manufacturers to consider when coming up with life science products. Ultimately, users and patients interact with your product, and those interactions inherently carry levels of varying risk.

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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

FDA Pulse Check: November 2018

By: Nick Schofield
December 4th, 2018

As the end of 2018 approaches, FDA is busy getting the last of this year’s regulatory activities wrapped up. Here are a few highlights of what they were up to in November.

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Thought Leadership

How to Keep Your Medical Device Organization Prepared for Regulatory Inspection

By: Nick Schofield
November 29th, 2018

In November 2018, FDA released its Medical Device Enforcement and Quality Report. In the report, the agency reveals how its initiatives on inspecting medical device manufacturers have grown in recent years. In the last decade alone, device inspections have increased by 46 percent.

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Thought Leadership

4 Tools and Strategies for Improving Complaint Management

By: Nick Schofield
November 27th, 2018

Life science organizations sometimes struggle in managing complaints; the postmarket environment and the surveillance necessary to monitor your product effectively can be difficult to stay on top of. However, there are a number of tools and strategies your organization can apply to get out of complaint management difficulties.

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Thought Leadership

What Your Development Team Can Learn from Users Hacking Their Medical Devices

By: Nick Schofield
November 21st, 2018

In November 2018, CNBC released a report on how some patients have been hacking their insulin pumps to augment how they manage their diabetes:

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Thought Leadership

Validating Product Development Software: Tips and Tricks

By: Nick Schofield
November 15th, 2018

Software validation is a common pain point for life science organizations. Ensuring the tools your teams use in your product development processes meet regulatory requirements and are performing in a safe and effective manner is a challenge many deal with. As life science industries move further away from paper-based product development to electronic systems, software validation only becomes more important. To address these issues, there are a few tips and tricks your organization can implement now that save time and effort down the road.

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Thought Leadership

5 User Needs Driving the Future of Medical Devices

By: Nick Schofield
November 13th, 2018

Our lives are rapidly evolving, thanks in part to the technological revolution of our current age. As our way of life changes, so too does the healthcare required to support it. This is forcing a massive disruption in the medical device industry. The user needs of the past are giving way to new ones, and planning for the changes now helps your organization prepare for the future of medical devices.

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Thought Leadership

5 Auditing Features You Want in Your Life Science Product Development Software

By: Nick Schofield
November 8th, 2018

Auditing is often a four-letter word in life science product development; even if you’re conducting one internally, audits can be a dreaded experience. However, they don’t have to be—especially if you’re using the right software. Here are five features of product development software you should be looking for when it comes to auditing activities.

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