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Get ready for MDR Kapstone Medical

How do we get ready for MDR?

High level areas to consider

 

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.

Kapstone Medical MDR series

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

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.

What You Missed Last Month – November Edition

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:

 

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

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

 

FDA's ASCA Pilot Program

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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Kapstone Medical is a single-source service provider to medical device companies lacking the appropriate human capital to bring to market new and safe products. We provide customized solutions that are flexible and cost effective in an ever changing regulatory environment.

 

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