Amazines Free Article Archive
www.amazines.com - Tuesday, May 24, 2022
Read about the most recent changes and happenings at Amazines.com
Log into your account or register as a new author. Start submitting your articles right now!
Search our database for articles.
Subscribe to receive articles emailed straight to your email account. You may choose multiple categories.
View our newest articles submitted by our authors.
View our most top rated articles rated by our visitors.
* Please note that this is NOT the ARTICLE manager
Add a new EZINE, or manage your EZINE submission.
Add fresh, free web content to your site such as newest articles, web tools, and quotes with a single piece of code!
Home What's New? Submit/Manage Articles Latest Posts Top Rated Article Search
Google
Subscriptions Manage Ezines
CATEGORIES
 Article Archive
 Advertising (133514)
 Advice (161571)
 Affiliate Programs (34788)
 Art and Culture (73834)
 Automotive (145676)
 Blogs (75393)
 Boating (9851)
 Books (17221)
 Buddhism (4129)
 Business (1329933)
 Business News (426412)
 Business Opportunities (366443)
 Camping (10969)
 Career (72776)
 Christianity (15844)
 Collecting (11639)
 Communication (115069)
 Computers (241908)
 Construction (38921)
 Consumer (49947)
 Cooking (17078)
 Copywriting (6730)
 Crafts (18205)
 Cuisine (7547)
 Current Affairs (20307)
 Dating (45901)
 EBooks (19700)
 E-Commerce (48246)
 Education (185373)
 Electronics (83517)
 Email (6439)
 Entertainment (159836)
 Environment (28922)
 Ezine (3040)
 Ezine Publishing (5452)
 Ezine Sites (1550)
 Family & Parenting (110928)
 Fashion & Cosmetics (196538)
 Female Entrepreneurs (11851)
 Feng Shui (132)
 Finance & Investment (310498)
 Fitness (106442)
 Food & Beverages (63005)
 Free Web Resources (7939)
 Gambling (30224)
 Gardening (25192)
 Government (10512)
 Health (629866)
 Hinduism (2206)
 Hobbies (44078)
 Home Business (91593)
 Home Improvement (251114)
 Home Repair (46208)
 Humor (4717)
 Import - Export (5456)
 Insurance (45103)
 Interior Design (29588)
 International Property (3488)
 Internet (191001)
 Internet Marketing (146661)
 Investment (22855)
 Islam (1161)
 Judaism (1352)
 Law (80455)
 Link Popularity (4596)
 Manufacturing (20901)
 Marketing (99268)
 MLM (14140)
 Motivation (18232)
 Music (26996)
 New to the Internet (9496)
 Non-Profit Organizations (4048)
 Online Shopping (129726)
 Organizing (7809)
 Party Ideas (11853)
 Pets (38070)
 Poetry (2229)
 Press Release (12687)
 Public Speaking (5639)
 Publishing (7561)
 Quotes (2407)
 Real Estate (126592)
 Recreation & Leisure (95456)
 Relationships (87647)
 Research (16180)
 Sales (80345)
 Science & Technology (110280)
 Search Engines (23496)
 Self Improvement (153285)
 Seniors (6216)
 Sexuality (35996)
 Small Business (49286)
 Software (83017)
 Spiritual (23466)
 Sports (116146)
 Tax (7659)
 Telecommuting (34072)
 Travel & Tourism (308166)
 UK Property Investment (3122)
 Video Games (13382)
 Web Traffic (11760)
 Website Design (56862)
 Website Promotion (36613)
 World News (1000+)
 Writing (35833)
Author Spotlight
SANTOSH GUPTHA

Certified Medical coder with 42 certifications,15 years experience in Medical records coding, HIPAA,...more
HANVEY HUANG

I'm a Chief Operated Officer from KIMKOO Mattress machinery.The pen is mightier than the sword.so I ...more
JOHN WHARTON

img border="0" height="22" src="3.bp.blogspot.com/-lwbCHWyiaZE/UkU4PxcWj8I/AAAAAAAAAA0/QooVAHCHbx4/...more
RAM SEWAK

Myself Ram Sewak possessing indepth domain experience of more than 10 years in SEO, SEM, Web Develop...more
JASON STEVE

Writing is my passion, Social media marketing is my love. I have written many articles on various ni...more


Selling Medical Devices in the EU-Medical Device Directive, CE & FDA -Webinar By GlobalCompliancePa by Webinar Web





Article Author Biography
Selling Medical Devices in the EU-Medical Device Directive, CE & FDA -Webinar By GlobalCompliancePa by
Article Posted: 09/11/2012
Article Views: 110
Articles Written: 38
Word Count: 310
Article Votes: 0
AddThis Social Bookmark Button

Selling Medical Devices in the EU-Medical Device Directive, CE & FDA -Webinar By GlobalCompliancePa


 
Health
Overview: Medical devices sold into the European Union (EU) must comply with the applicable medical device directives, EU laws similar to FDA's regulations. Medical devices declared compliant must bear a CE mark in order to be admitted into the 29 member countries comprising the EU. The market population of these 29 countries is 450 million people, exceeding the 420 million people served by NAFTA (USA, Canada & Mexico), so many companies have an interest in penetrating this market. This presentation will provide an explanation in layman's terms of the various routes to CE marking of medical devices, with a focus on the Medical Device Directive, MDD 93/42/EEC.

Areas Covered in the Session: New approach directives & background IVD, MDD & Active Implantable Directive Competent Authorities & Notified Bodies Medical Device Directive Device classification Routes to CE marking under various MDD annexes Technical files Essential requirements checklists ISO 13485:2003 Quality System Certification

Who Will Benefit: Companies wishing to penetrate the EU market for medical devices or sharpen their skills will receive practical guidance on achieving the CE mark. Employees who will benefit include: Quality & Regulatory Professionals Manufacturing & Design Engineers Marketing Product Managers

John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.

AMAZINES.COM

Related Articles - Online Training, CE, FDA, EU-Medical Device, MDD 93/42/EEC, IVD, NAFTA,

Email this Article to a Friend!

Receive Articles like this one direct to your email box!
Subscribe for free today!

 Rate This Article  
Completely useless, should be removed from directory.
Minimal useful information.
Decent and informative.
Great article, very informative and helpful.
A 'Must Read'.

 

Do you Agree or Disagree? Have a Comment? POST IT!

 Reader Opinions 
Submit your comments and they will be posted here.
Make this comment or to the Author only:
Name:
Email:
*Your email will NOT be posted. This is for administrative purposes only.
Comments: *Your Comments WILL be posted to the AUTHOR ONLY if you select PRIVATE and to this PUBLIC PAGE if you select PUBLIC, so write accordingly.
 
Please enter the code in the image:



 Author Login 
LOGIN
Register for Author Account

 

Advertiser Login

 

ADVERTISE HERE NOW!
   Limited Time $60 Offer!
   90  Days-1.5 Million Views  

 

Great Paranormal Romance


STEPHEN BYE

Steve Bye is currently a fiction writer, who published his first novel, ‘Looking Forward Through The...more
LAURA JEEVES

At LeadGenerators, we specialise in content-led Online Marketing Strategies for our clients in the t...more
STEVERT MCKENZIE

Stevert Mckenzie, Travel Enthusiast. ...more
SHALINI MITTAL

A postgraduate in Fashion Technology. Shalini is a writer at heart! Writing for her is an expression...more
GENE MYERS

Author of four books and two screenplays; frequent magazine contributor. I have four other books "in...more
ALEX BELSEY

I am the editor of QUAY Magazine, a B2B publication based in the South West of the UK. I am also the...more
NEVIO GARDASANIC

Hello, my name is Nevio Gardasanic. If you want to go beyond being just a perpetual beginner at thin...more
SANJIB DAS

Sanjib Kumar Das is an Indian business enthusiast and entrepreneur who is motivated to help small an...more
AKSHAY CHOPRA

Akshay Chopra is an experienced certified personal trainer and the founder of WERSTUID. An organizat...more
TIM FAY

I am not a writer nor am I trying to become a writer. I am an average person with average intelligen...more

HomeLinksAbout UsContact UsTerms of UsePrivacy PolicyFAQResources
Copyright © 2022, All rights reserved.
Some pages may contain portions of text relating to certain topics obtained from wikipedia.org under the GNU FDL license