BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

ProTip SAS Achieves ISO 13485 Certification and Obtains CE Mark for its Intra-Laryngeal Implant 'Newbreez'


6/15/2011 10:28:19 AM

Strasbourg, France, June 15th, 2011 - ProTip SA, a medical device company dedicated to finding innovative solutions for patients suffering from larynx malfunctions, today announced that the company has achieved ISO 13485 Certification. ISO 13485 is an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive quality management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union (EU). It has also obtained the CE mark for its intra-laryngeal implant, ‘NewBreez’, confirming that it conforms to EU regulations for medical devices.

Obtaining these approvals opens the way for ProTip to begin manufacturing and selling activities.

"ISO 13485 Certification confirms that our manufacturing and quality systems meet the high required standards of medical device companies,” said Maurice Bérenger, CEO of ProTip. “Our employees have shown a great deal of cross-functional diligence and hard work in obtaining this certificate. The reward is that it allows us to expand internationally and to start serving ENT patients across Europe.”

About ProTip SA

ProTip SA is a privately held medical device company dedicated to finding innovative solutions for patients suffering from larynx malfunctions. Its initial focus is to develop a permanent implant for Laryngectomy patients. ProTip, based in Strasbourg, in Eastern France, was founded in 2004 and has since benefited from strong support from the Alsace region and Oseo, the French government innovation agency. The company has won several prestigious awards in France. It has established partnerships with a number of academic establishments and has recently strengthened its ties with the University Hospitals of Strasbourg and with Inserm. A team of experienced managers is in place with the objective of accelerating international company development.

http://www.protipmedical.com

Mark Tidmarsh

ANDREW LLOYD & ASSOCIATES

http://www.ala.com

mark@ala.com

Brighton Business Centre 95 Ditchling Road Brighton BN1 4ST ENGLAND

Tel: +44 1273 675100

Fax: +44 1273 675400

55 rue Boissonade 75014 Paris FRANCE

Tel: +33 1 56 54 07 00

Fax: +33 1 56 54 07 01

INTERNATIONAL TECHNOLOGY MARKETS, STRATEGY & COMMUNICATION



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES