FDAnews Announces -- Implementing Clinical and Performance Evaluation Reports for Your Medical Device: Best Practices for Getting them Right Webinar, June 2, 2020

Error message

Notice: Undefined property: stdClass::$ds_changed in eval() (line 16 of /var/www/7/modules/php/php.module(80) : eval()'d code).
Notice: Undefined property: stdClass::$ss_search_api_url in eval() (line 20 of /var/www/7/modules/php/php.module(80) : eval()'d code).
Notice: Undefined property: stdClass::$tm_title in eval() (line 20 of /var/www/7/modules/php/php.module(80) : eval()'d code).
Notice: Undefined property: stdClass::$ds_changed in eval() (line 16 of /var/www/7/modules/php/php.module(80) : eval()'d code).
Notice: Undefined property: stdClass::$ss_search_api_url in eval() (line 20 of /var/www/7/modules/php/php.module(80) : eval()'d code).
Notice: Undefined property: stdClass::$tm_title in eval() (line 20 of /var/www/7/modules/php/php.module(80) : eval()'d code).

In order to obtain or maintain a CE Mark to sell or distribute devices in the EU, one must

Metadata

Provider:

PR Newswire

Retrieved on:

Tuesday, May 19, 2020

Information

Tags:

CE marking, European Economic Area, Medical device, Regulation (EU) No. 305/2011, MDR

Geotags:

Virginia

Organisation:

FDANEWS

Website:

https://www.fdanews.com

Summary

Key Points:

In order to obtain or maintain a CE Mark to sell or distribute devices in the EU, one must
meet the requirements of the EU's Medical Device Regulation (EU-MDR) and/or In-vitro Diagnostic Device Regulation (EU-IVDR).
Notified bodies (NBs) are now more strictly enforcing clinical and performance evaluation requirements.
Understand the Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs) and one will be well on the way to obtaining or maintaining a CE Mark.
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

FDAnews Announces -- Implementing Clinical and Performance Evaluation Reports for Your Medical Device: Best Practices for Getting them Right Webinar, June 2, 2020

FALLS CHURCH, Va., May 19, 2020 /PRNewswire-PRWeb/ -- Implementing Clinical and Performance Evaluation Reports for Your Medical Device
Best Practices for Getting them Right
An FDAnews Webinar
Tuesday, June 2, 2020, 1:30-3:00 p.m. EDT
https://www.fdanews.com/clinicalevaluationmd

In order to obtain or maintain a CE Mark to sell or distribute devices in the EU, one must
meet the requirements of the EU's Medical Device Regulation (EU-MDR) and/or In-vitro Diagnostic Device Regulation (EU-IVDR). Notified bodies (NBs) are now more strictly enforcing clinical and performance evaluation requirements.

Understand the Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs) and one will be well on the way to obtaining or maintaining a CE Mark.

In this webinar, Jon Gimbel, Ph.D., executive director at Regulatory and Quality Solutions, will explain:

•EU-MDR requirements for clinical evaluations and IVDR requirements performance evaluations
•Ideas for recommended CER and PER structures
•How literature searches can be used within these evaluations
•Common NB findings and pitfalls, including those related to equivalence and measurable objectives
•Strategies for overcoming common NB findings and pitfalls, including properly justifying equivalence and data presentation

This webinar will guide attendees to a deeper understanding of what a company must do to meet the EU-MDR and EU-IVDR requirements, how to manage any necessary adjustments and how to get ahead of any potential issues.

Ensure CE Mark success.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
Implementing Clinical and Performance Evaluation Reports for Your Medical Device
Best Practices for Getting them Right
An FDAnews Webinar
Tuesday, June 2, 2020, 1:30-3:00 p.m. EDT
https://www.fdanews.com/clinicalevaluationmd

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/clinicalevaluationmd
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

SOURCE FDAnews