InvestorsHub Logo
Followers 2770
Posts 77901
Boards Moderated 1
Alias Born 05/10/2007

Re: cubinvestor1 post# 113530

Sunday, 09/26/2010 7:34:30 PM

Sunday, September 26, 2010 7:34:30 PM

Post# of 212601
You hire somebody who handles this. Here is one of the bigger and most reputable of these firms, Quinteles. They are handling Europe for one of my other favorite stocks.


For Medical Devices
Services to Support Medical Device Development

In a world of challenging and dynamic regulation, effective management of regulatory issues is essential to the maintenance of your business and to new product introduction. This environment creates the need for robust systems and detailed knowledge of medical device requirements.

Quintiles helps medical device companies bring products to market – and keep them there – by efficiently and cost-effectively providing the right regulatory, clinical development and post-approval programs. We help you to:

* Plan and execute clinical trials
* Prepare documentation, such as:
o 510(k)
o IDE
o PMA
o PDP
o CE Mark submissions
* Design quality systems
* Develop reimbursement strategies
* Meet post-marketing surveillance requirements

The goal is to provide you with a full spectrum of services that help you meet the requirements of the Medical Device Directives (AIMDD and MDD), the In Vitro Diagnostics Directive and related directives.


About Quintiles

Quintiles is the only fully integrated bio and pharmaceutical services provider offering clinical, commercial, consulting and capital solutions. Our 23,000 employees in 60 countries have helped develop or commercialize all of the top 30 best-selling drugs.

http://www.quintiles.com/clinical-services/medical-devices/