5 Signs Your Quality Management System Needs an Upgrade

Most medical device companies already have a QMS in place. It’s hard to track, document, and validate any of your [..]

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What is an ISO certification and what role does it play in the medical device industry?

In order to commercialize medical devices in accordance with international standards, medical device and [..]

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4 Questions to Ask Before Submitting a 510(k)

So you’re an inventor who wants to develop a medical device and use the invention in practice. You know the FDA [..]

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Explore the Changes to Medical Device Classification Under EU MDR

The European Medical Device Regulation (MDR) replaced the Medical Device Directive (MDD) in May of 2017. However, [..]

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Three Key Differences Between MDD and MDR

Adapting to The EU Medical Device Regulation (MDR) Medical device companies hoping to bring their products to [..]

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The Pro’s and Con’s of Medical Device Materials

  Medical Device Material Selection: Pros and Cons Medical Device Companies Need to Know Material selection is one [..]

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5 Ways Medical Device Development Companies Can Save Money When Developing Products

A Conversation With John Kapitan | Founder & CEO, Kapstone Medical Medical device development companies large and [..]

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Using Competitor Research Throughout the Medical Device Product Development Lifecycle

A Conversation With David Walsh | Director of Engineering   According to David Walsh, Director of Engineering at [..]

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Solving The Top 4 Challenges Medical Device Companies Face When Developing New Products

A Conversation With Justin Rowland | Project Manager Bringing a medical device to market is difficult for startup [..]

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510(k) Premarket Notifications: How to Determine Substantial Equivalence

A Conversation with Kellen Hills | Regulatory Affairs Specialist, Kapstone Medical Since 1906, the US Food and [..]

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How Outsourced Regulatory Affairs Consultation Can Save Your Medical Device Company Time and Money

A Conversation with John Kapitan | Founder & CEO, Kapstone Medical Bringing a medical device to market is a [..]

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European MDR: EUDAMED Database and UDI

Part 7 in a 7-part series on the EU’s Medical Device Regulation The European Database for Medical Devices [..]

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