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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FDA | Thought Leadership

Determining if Your Medical Device is Appropriate for the Special 510(k) Program

By: Nick Schofield
September 19th, 2019

In September 2019, FDA released final guidance on its Special 510(k) Program. This optional pathway allows medical device manufacturers a simplified approach to submitting changes to their legally marketed products, provided they are currently well-understood by the agency. However, figuring out whether or not your submission qualifies under the Special 510(k) is tricky. Diving into the final guidance, there are hallmarks you can use to understand your device’s qualification under this program.

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Thought Leadership

10 Tips for Streamlining Your Search for Compliance Software Tools

By: Nick Schofield
September 17th, 2019

Your organization has decided it needs a compliance software tool—now what? Well, conducting a search is a good place to start. However, your search for a new tool needs to be well-informed and methodical. Otherwise, you might wind up with a tool that’s not mature enough or inappropriate for your needs. To avoid these issues and streamline your search, here are some tips that can help.

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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

What Do You Need to Comply with the EU MDR Postmarket Requirements?

By: Nick Schofield
September 12th, 2019

The deadline for the official implementation of the EU Medical Device Regulation (MDR) is approaching. By May 2020, your medical device organization must be in compliance with many new requirements for your product throughout its life cycle. With this increased focus on the total product life cycle comes an expanded suite of regulations for postmarket surveillance you must be in compliance with. There is a lot to unpack in this aspect of EU MDR, but there are some major compliance areas your organization should be putting in place now.

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Thought Leadership | Industry Updates

FDA Pulse Check: August 2019

By: Nick Schofield
September 4th, 2019

It’s been quite a summer for FDA. Between a number of recalls, product approvals, releases of consumer information, and updates to key agency programs, there’s a lot to catch up on. Here are a few of the highlights we think are worth keeping an eye on.

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Thought Leadership | Regulatory Compliance

Common Questions About the Upcoming EU MDR

By: Nick Schofield
August 27th, 2019

The new European Medical Device Regulation (EU MDR) is on its way. Soon, medical device manufacturers wishing to submit to European markets will need to comply with a set of new and critically important regulations. However, even with the 2020 deadline coming up, many organizations are still in the dark about what the MDR is and what it means for them. Here are some common questions we’ve heard about this new European regulation and what it means for your product development and compliance activities.

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Thought Leadership

Developing Better Use Specifications for Life Science Products

By: Nick Schofield
August 22nd, 2019

There’s so much work that already goes into the development of life science products before even thinking about the necessary compliance steps. This high volume of work often leads development teams to push away compliance activities until later on, which can actually lead to rework and other negative consequences. Yet one compliance avenue that can get folded into this shuffle is your product’s use specification.

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Thought Leadership

7 Questions to Guide Compliance Software Adoption in Your Organization

By: Nick Schofield
August 15th, 2019

So, you’ve decided to adopt a compliance software tool into your life science organization as part of your product development activities. Congratulations! Now that you’ve made that big decision, here comes the tough part: transition and implementation.

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Thought Leadership

How to Tell if Your Life Science Organization Needs Compliance Software Tools

By: Nick Schofield
August 8th, 2019

Does your life science organization need to adopt a compliance software tool?

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Thought Leadership

7 Reasons to Consider Adopting Compliance Software Tools

By: Nick Schofield
August 1st, 2019

Many organizations tend to stick with what’s worked for them in the past for regulatory compliance due to its complexities and the need to assure that new products are safe and effective. This is especially true when it comes to compliance activities such as design controls. While this attitude is understandable, it does present some problems. It can limit an organization’s ability to remain competitive in the market, and it can also impede long-term business growth.

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