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:3/27/2020)... LAKE MARY, Fla. (PRWEB) , ... March 27, 2020 , ... ... a three-month online educational health conference for people with asthma, their families and caregivers ... 24-hours a day between March 27, 2020 and June 30, 2020, and will focus ...
(Date:3/22/2020)... ... ... In partnership with UC Health, Cincy Shirts has created a new t-shirt design entitled ... comes from the English translation of “Juncta Juvant”, the City of Cincinnati’s motto found ... sale of the shirt will benefit the YMCA of Cincinnati Emergency Response Fund that ...
(Date:3/20/2020)... ... ... My heart goes out to those across our nation and around the world ... through similar circumstances - underlying conditions compounded by a virus – I truly empathize. ... emotions just like many have: fear, anxiety, uncertainty. In contrast, I would like to ...
(Date:3/19/2020)... ... , ... Therapies of The Rockies has Colorado’s back, and they are here ... telepractice patients across the country, as remote therapy services have no geographic boundaries. Reach ... your services safely! , Therapies of The Rockies is a Denver-area speech, language, occupational, ...
(Date:3/19/2020)... (PRWEB) , ... March 19, 2020 , ... Van Dyk ... current operator, Family of Caring, on October 3, 2018 and is not involved in ... the recent news involving Family of Caring at Montclair. , “We are devastated to ...
Breaking Medicine News(10 mins):
(Date:3/20/2020)... (PRWEB) , ... March 20, 2020 , ... New Alliance ... successful and productive life, as well as encourages those interested in pursuing tertiary studies ... students is whether adolescents who attend the school have a good chance of progressing ...
(Date:3/19/2020)... ... March 19, 2020 , ... The Pulmonary Hypertension ... Clinic in Cleveland; University of Nebraska Medical Center in Omaha, ... PHA Centers of Comprehensive Care (CCC) as part of its Pulmonary Hypertension Care ...
(Date:3/16/2020)... ... 2020 , ... In the wake of the COVID-19 pandemic, Curogram , ... ramping efforts to help the containment of the global disease with its virtual clinic, ... or EMR system. , “Our goal is to minimize exposure and maximize providers’ ...
Breaking Medicine Technology: