Navigation Links
Upcoming Webinar Hosted by Xtalks: Are You Prepared for the New Requirements of the EU’s Medical Device Regulation?
Date:2/19/2020

In 2017, the EU’s revamped Medical Device Regulation (MDR) was published, which expanded the scope of regulations and requirements that currently govern medical device manufacturers under the Medical Devices Directive (MDD); the timeline provided by MDR was three years, which extends until 25 May 2020. Major changes from the previous MDD include:

  • Elimination of the “grandfathering” mechanism, which necessitates that all medical devices on the market must apply to be accredited, regardless of whether or not they were previously approved under earlier directives
  • Empirical evaluation and testing that demonstrates that devices are biocompatible, in alignment with ISO 10993-1:2018, and not merely relying on historical data that supports a device’s safety
  • Documentation that medical devices do not contain carcinogens, mutagens, or reproductive toxic substances. This can be accomplished by identifying and quantifying the materials that compose the medical device above 0.1 percent (by weight)

Join Scott Graham, PhD, Team Leader at EAG and Carolyn J. Otten, PhD, Senior Manager of Analytical Services at EAG in a live webinar on Thursday, March 5, 2020 at 2pm EST (11am PST) to learn about:

  • What manufacturers need to know about the EU MDR
  • Overview of the scope of testing, the analytical approach and turnaround times involved to address new MDR requirements
  • Three examples of the types of tests offered by Eurofins EAG, presented as case studies
  • Extractables and leachables studies
  • Potential follow-up steps after testing

This webinar will be followed by a live Q&A with the featured speakers.

For more information or to register for this event, visit Are You Prepared for the New Requirements of the EU’s Medical Device Regulation?

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

Read the full story at https://www.prweb.com/releases/upcoming_webinar_hosted_by_xtalks_are_you_prepared_for_the_new_requirements_of_the_eus_medical_device_regulation/prweb16919067.htm.


'/>"/>
Source: PRWeb
Copyright©2020 Vocus, Inc.
All rights reserved


Related medicine news :

1. Applications of Immunosequencing in Autoimmunity, Upcoming Webinar Hosted by Xtalks
2. Building an Effective Global Supply Chain Through Implementation of Successful IOR Strategies, Upcoming Webinar Hosted by Xtalks
3. Speed Study Start-Up: People, Process, and Technology Pillars, Upcoming Webinar Hosted by Xtalks
4. Workflow-as-a-Service: Delivering Operational Consistency, Quality & Reproducibility to Preclinical Pharma, Upcoming Webinar Hosted by Xtalks
5. Implementing Syndromic Multiplex PCR for Pneumonia within an Antimicrobial Stewardship Program, Upcoming Webinar Hosted by Xtalks
6. Best Practices in Seasonal Vaccine Studies, Upcoming Webinar Hosted by Xtalks
7. Cognition® Corporation Releases White Paper Upcoming EU Regulation of Medical Devices
8. Laurence Fishburne Hosts an Upcoming "Behind The Scenes" Episode on Heart Disease
9. Evolution of Clinical Trial Supply Chain Flexibility, Upcoming Webinar Hosted by Xtalks
10. Laurence Fishburne Hosts An Upcoming "Behind The Scenes" Episode on Heart Disease
11. Albert Einstein Offers Today’s Physicians an Important Clue on How to Prevent and Relieve Burnout at Upcoming CME Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/1/2020)... ... ... Velocidy Bio ’s Dutch biotech partner, Molecular Biology Systems (MBS), has ... time for SARS-CoV-2 to eight minutes, compared to current systems that take over an ... a hundred and eighty (180) amplification runs a day, an almost ten-fold increase over ...
(Date:4/1/2020)... ... 01, 2020 , ... “Medical information is considered to be ... Grover LLP attorney Eric A. Grover. “For that reason, healthcare providers are ... and disclosure of medical information can, under certain circumstances, give rise to claims ...
(Date:3/30/2020)... ... 30, 2020 , ... Frontline Public Safety Solutions is living ... effort to keep frontline officers and the public safe in the face of ... minimizing direct contact. They are also freeing up 911 lines for genuine emergencies ...
(Date:3/28/2020)... , ... March 27, 2020 , ... ... of life as COVID-19 cases grow by the day, people of all ages ... language disorders—who have difficulties with social interactions in the best of times—the physical ...
(Date:3/28/2020)... (PRWEB) , ... March 27, 2020 , ... ... practice OrthoSC is now offering telemedicine as an alternative approach to ... of the practice’s doctors in the comfort of their own home or office ...
Breaking Medicine News(10 mins):
(Date:4/1/2020)... ... April 01, 2020 , ... ... to sign up today, with the first live-streaming broadcast premiering on April 2. ... feature a host interviewing a variety of animal keepers and veterinary hospital staff ...
(Date:3/30/2020)... ... 30, 2020 , ... FastMed Urgent Care , one of the nation’s ... fastmed.com . FastMed is offering its COVID-19 self-assessment tool as a free public service ... brief series of questions that help assess the risk of coronavirus. , While ...
(Date:3/28/2020)... MARIN, Calif. (PRWEB) , ... March 27, 2020 , ... ... Skincare line, Wendy May Real has launched a new hand sanitizer in response to ... the niche hand sanitizer market will continue to expand during the next several months ...
Breaking Medicine Technology: