European MDR: Product Portfolios and Technical Documentation

December 12, 2019 / by Kapstone Medical / 4 minute read

Part 4 in our 7-part series on meeting the new requirements under the EU MDR

Complying with the European Union’s Medical Device Regulation (MDR) poses a daunting task for medical device makers marketing products inside the EU. One of the most taxing efforts for companies that already have CE-marked devices in the EU is the need for portfolio reviews.

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European MDR: How do we get ready for MDR?

November 21, 2019 / by Kapstone Medical / 5 minute read

Second in a 7-part series on the EU’s Medical Device Regulation

The new Medical Devices Regulation (2017/745/EU), or more commonly referred to as the EU MDR, poses significant challenges to medical device makers that want to market their products in the European Union.

The clock is already ticking and the three-year transition period is counting down to 26 May 2020, which is the “Date of Application” (DoA) of the Regulation.

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What is European MDR and Why It happened, Timelines for Compliance

November 13, 2019 / by Kapstone Medical / 4 minute read

First in a 7-part series on the EU’s Medical Device Regulation

The European Parliament passed the Medical Device Regulation (MDR) two years ago and began a three-year transition period in May 2017 with enforcement set to begin in May 2020.

The new regulation repeals and replaces the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD), effectively pushing the reset button for medical device makers who sell products in Europe.

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FDA lists proposed guidance publications for 2019

October 30, 2018 / by Kapstone Medical / 1 minute read

The FDA issued its list of proposed guidance publications for 2019 on Oct. 5 as part of its agreement to speed approvals of medical devices in exchange for additional funding from industry.

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What You Missed Last Month September

October 29, 2018 / by Kapstone Medical / 1 minute read

September was a busy month for the 3D printing industry. There has been new insight on additive manufacturing and how to handle the latest Medical Device Regulation, a woman’s collapsed ankle was restored with a 3D printed ankle implant, and a new report shows that the medical additive manufacturing field will see significant growth in the coming years. Here is a quick look at what you missed last month:

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FDA Sets Priorities for 2016: What Does It Mean for Medical Devices?

March 16, 2016 / by MedTech Momentum / 1 minute read

It’s the year of Big Data, and FDA has slated several priorities for fiscal year 2016 to improve regulatory science and introduce revised data quality standards.
From leveraging Big Data for regulatory decision making, to enhancing diverse population data for clinical trials and studies, the agency’s 2016 goals are guided by the medical device industry’s call for increased participation, transparency, and overall quality. What do these changes mean for medical devices?

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What You Missed Last Month (August 2015 Edition –Medical Device & 3D Printing)

September 16, 2015 / by Kapstone Medical / 1 minute read

It’s back to school with Team Kapstone! In August, we picked up educational and inspirational stories in 3D printing, medical device, and orthopedics. Here’s your August “What You Missed” reading list - three articles to Inspire, Equip, and Guide you through the last month:

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What You Missed Last Month (July 2015 Edition –Medical Device & 3D Printing)

August 12, 2015 / by Kapstone Medical / 2 minute read

While you were enjoying your summer vacation, Team Kapstone compiled some of the best stories in 3D printing, medical devices, and orthopedics. Catch back up with three articles to Inspire, Equip, and Guide you through what you missed in July:

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What You Missed Last Month (May 2015 Edition- Medical Device & 3D Printing)

June 10, 2015 / by Kapstone Medical / 3 minute read

Additive manufacturing, or 3D Printing, is dominating spring medical device industry headlines, and at halfway through the year, it’s slated to be on the Top 5 list of Kapstone Medical’s most inspiring and thought-provoking topics of 2015.

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4 Questions to Ask Before Submitting a 510(k)

March 5, 2015 / by Kapstone Medical / 2 minute read

So you’re an inventor who wants to develop a medical device and use the invention in practice. You know the FDA regulates medical devices, but that’s about as far as your knowledge takes you.

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