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Event Manager
Compliance4all
161 Mission Falls Lane, Suite 216
Fremont, CA 94539
(800) 447-9407

Event Description

Overview:
As industry is aware of, now you must deal with the new requirements for Clinical Evaluation Reports (CER's) if you sell all classes of medical devices in Europe. As of March 21, 2010 all medical devices, including Class I and Class IIa, will be required

Areas Covered in the Session:
Understand the Essential Requirements and the relationship to the CER
Prepare and execute a literature review
Define the elements comprising the CER and recommended format
Construct and manage the Technical File
Understand the expectation that devices sold in Europe must have a CER in it's Tech File unless you justify otherwise
Learn what resources exist to guide you in developing a clinical evaluation report, including how to select a format for writing it and keeping it updated

Who Will Benefit:
This webinar will provide valuable assistance and guidance to companies who need to better understand the goal of the CER, the format and contents. The employees who will benefit include:
All end-users from appropriate departments who desire or require a better understanding or a refresh knowing that every medical device sold in Europe must be supported with a Clinical Evaluation Report in its technical file.
QA/Compliance
Regulatory Affairs Management and RA Specialists
Marketing
Consultants
Clinical Affairs

Speaker Profile:
David Dills , Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://www.compliance4all.com/control/w_product/~product_id=500841LIVE?channel=mailer&camp=webinar&AdGroup=eventsinamerica_Dec_2016_SEO
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Not sure if you want to exhibit at or attend the Training by Compliance4all on Clinical Evaluation Reports? See the panels below to get the information you need to make an informed decision.

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Event Details

Website: http://www.compliance4all.com/control/w_product/~product_id=500841LIVE...
Conference/Event Dates: 12/14/2016 - 12/14/2016
Conference/Event Hours: 60 Minutes
Classification: B2B
Primary Industry: Clinical Pharmacology
Other Industries: Clinical Pharmacology, Professional Healthcare
Cost to Attend: One Dial-in One Attendee Price: US$150.00
Audience: All end-users from appropriate departments who desire or require a better understanding or a refresh knowing that every medical device sold in Europe must be supported with a Clinical Evaluation Report in its technical file.
QA/Compliance
Regulatory Affairs Management and RA Specialists
Marketing
Consultants
Clinical Affairs
Number of Exhibitors:1

Booth Details

Booth Size Booth Cost   Available Amenities
No Exhibiting   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: n/a
Other Booth Sizes Available: n/a

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