European MDR: Notified Bodies

December 4, 2019 / by Kapstone Medical / 3 minute read

Part 3 in our 7-part series on meeting the new requirements under the EU MDR

If you are new to obtaining marketing approval in the European Union, the concept of Notified Bodies is one of the most significant differences from the US FDA system or regulatory oversight.

A Notified Body is an independent certification organization that is “notified” by an EU member state’s Competent Authority, usually the ministry of health, to certify that a product meets the applicable requirements for CE marking.

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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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What You Missed Last Month – January Edition

February 4, 2019 / by Kapstone Medical / 1 minute read

Artificial Intelligence and 3D Printing are making history in the medical device world. From AI manufacturing machines to the creation of 3D printed organs to more streamlined processes by the FDA to approve 3D medical devices. Here is a quick overview of what you missed:

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What You Missed Last Month – December Edition

January 31, 2019 / by Kapstone Medical / 1 minute read

From 3D printed light receptors for prosthetic vision devices to $10 3D ultrasound chips and 3D printing for spinal cord injuries to 3D printed model body parts, a lot went on in the month of December. Here is a quick overview of what you missed:

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What You Missed Last Month – November Edition

December 29, 2018 / by Kapstone Medical / 2 minute read

Lots went on in the 3D Printing field last month. From 3D printed light receptors for prosthetic vision devices to $10 3D ultrasound chips and 3D printing for spinal cord injuries to 3D printed model body parts, a lot went on in the month of November. Here is a quick overview of what you missed:

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FDA Approves First Continuous Glucose Monitoring System Not Requiring Blood Sample Calibration

December 26, 2018 / by Kapstone Medical / 1 minute read

The FDA approved last July the first continuous glucose monitoring system that could free millions of people with diabetes from daily finger sticks.

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FDA's ASCA Pilot Program

December 20, 2018 / by Kapstone Medical / 1 minute read

Agency publishes details for conformity assessment

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published additional information on its pilot program for medical device conformity assessment accreditation, known as the Accreditation Scheme for Conformity Assessment, or ASCA.

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BioLIFE4D Has Successfully 3D Printed Human Cardiac Tissue

December 11, 2018 / by Kapstone Medical / 2 minute read

BIOLIFE4D announced earlier this year that it has successfully 3D printed human cardiac tissue demonstrating the ability to 3D bio-print viable tissue for transplant.

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Heart Implant, 3D Printed to Order

December 7, 2018 / by Kapstone Medical / 2 minute read

For patients with heart rhythm disorders, current pacemakers and implantable cardioverter defibrillators are “one-size-fits- all” devices that provide narrowly limited information for cardiologists treating patients with the devices.

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