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Visualizing a Medical Device through Illustrations, Animations, and other Artwork - Featured Image

Visualizing a Medical Device through Illustrations, Animations, and other Artwork

Imagine using medical illustrations, animations, and other types of artwork to tell the story of a m...
Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device? - Featured Image

Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device?

If your medical device falls under premarket submission criteria, there are three types of 510(k) th...
Virtual Auditing in a Post-COVID World of Digital Compliance - Featured Image

Virtual Auditing in a Post-COVID World of Digital Compliance

What do auditing and compliance protocols look like during a pandemic? Medical device companies cont...
Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View - Featured Image

Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View

Keeping a constant pulse on current medical device industry standards for risk management, like ISO ...
Prioritizing Medical Device Reimbursement During Product Development - Featured Image

Prioritizing Medical Device Reimbursement During Product Development

Medical device reimbursement is a key consideration that must be well researched, understood, and ma...
Change Management Process Explained in 6 Easy Steps (+ free template) - Featured Image

Change Management Process Explained in 6 Easy Steps (+ free template)

In Prosci’s research, participants were six times more likely to meet project goals by following an ...
Understanding and Handling Different Types of Feedback - Featured Image

Understanding and Handling Different Types of Feedback

What’s the relationship between product feedback, complaints, and adverse events? 
How to Use the De Novo Pathway for your Medical Device - Featured Image

How to Use the De Novo Pathway for your Medical Device

Is the De Novo regulatory pathway a viable option to get your medical device to market?
How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist) - Featured Image

How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

So you need to make a change to your medical device, what now?
Understanding Change Management and Change Control in the Medical Device Industry - Featured Image

Understanding Change Management and Change Control in the Medical Device Industry

Change is inevitable in the medical device industry. Innovative device companies are at the constant...
Are you Spending Enough Time Defining and Managing Requirements for your Medical Device? - Featured Image

Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

Some sources claim that one-third of your product development project should be spent on defining go...
Top 100 Medical Device Startups with Most Money Raised in 2020 (Free Chart) - Featured Image

Top 100 Medical Device Startups with Most Money Raised in 2020 (Free Chart)

The first half of 2020 brought record-breaking investment totals for health care companies, accordin...

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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