Insights

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

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

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

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

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

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

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

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

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

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

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

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