Company Profile
QualiMed was found in 1997 by Martina Schmitt, Manfred Gülcher and Thomas Nissl as an OEM manufacturer for implantable medical devices with a focus on the development and regula-tory approval of coronary stents and their respective delivery devices. Later the business was expanded to peripheral vascular and non vascular implants that included the world’s first remov-able pulmonary, esophageal, and biliary stents. In the last two years QualiMed started with the development of various biodegradable technologies, drug device combination products, and or-thopaedic implants as part of its diversification strategy. Up to date QualiMed has obtained CE approvals for more than 70different products mainly for stents and stent delivery systems. Also, QualiMed developed over 5 Drug Eluting Stents of which it has three (3) CE approvals utilizing bio stable polymers and two more based on biodegradable polymer coatings which are in the regulatory phase of the approval process. The company also has a number of the products it has developed that have been both CE & FDA approved and is the current sole source manufacture of these technologies.
Manufacturing is organised in the plant outside of Hamburg Germany in the town of Winsen where QualiMed runs two Class Clean rooms according to EEC GMP standards. The company has production capabilities for stents, catheters, drug device combination products, and biodegradable technologies for a variety of interventional and surgical applications.
In 2008 Eric K. Mangiardi joined the Board of Directors at QualiMed as an active investor with a primary focus to assist the company in the development and implementation of its strategic plan, operational growth including capacity enhancement, and product diversification strategy.
QualiMed is the holder of more than 70 patents and utility models World Wide
Board of Directors
- Martina Schmitt
- Mrs MARTINA SCHMITT is Co-Managing Director and Partner at QualiMed and is responsible for the manufacturing plant and leads the Operational activities at QualiMed. Her focused expertise is in the areas of plastics and she is in charge of all catheter based projects in the company. Before QualiMed Mrs. Schmitt has been working on the installation and management of production facilities at Devon Medical Hamburg, Germany and the establishment and growth of an OEM-testing laboratory at EDAG AG. Previous to that she held executive positions in the automotive industry with a focus on materials technology.
- Manfred Guelcher
- Mr. MANFRED GUELCHER is Co- Managing Director and Partner at QualiMed and a specialist for regulatory affairs. He is also responsible for governmental and EU funded R&D cooperation projects and is in charge of some of the companies diverse development projects following innovative strategies in cardiac treatment like myocardial regeneration by retro infusion. Previous to the foundation of QualiMed Mr. Guelcher worked as manager for quality and regulatory affairs at DEVON MEDICAL, Hamburg , Germany and as an auditor for medical devices at DEKRA (notified body), Stuttgart, Germany
- Eric K Mangiardi
- Mr. ERIC K. MANGIARDI joined the Board of Directors and Management Team of QualiMed as an active investor with a focus on strategic and operational development and growth Mr. Mangiardi was formerly the President and CEO of a US based international medical device Company (Alveolus Inc., Charlotte, NC, USA) Previous to his work at Alveolus Mr Mangiardi held various senior positions in the IT and Medical Device sector
Executive Management
- Martina Schmitt
- Mrs MARTINA SCHMITT is Co-Managing Director and Partner at QualiMed and is responsible for the manufacturing plant and leads the Operational Act ivies at QualiMed. Her focused expertise is in the areas of plastics and she is in charge of all catheter based projects in the company. Before QualiMed Mrs. Schmitt has been working on the installation and management of production facilities and the establishment and growth of an OEM-testing laboratory at Devon Medical, Hamburg, Germany. Previous to that she held executive positions in the automotive industry with a focus on materials technology.
- Manfred Guelcher
- Mr. MANFRED GUELCHER is Co-Managing Director and Partner at QualiMed and a specialist for regulatory affairs. He is also responsible for governmental and EU funded R&D cooperation projects and is in charge of some of the companies diverse development projects following innovative strategies in cardiac treatment like myocardial regeneration by retro infusion. Previous to the foundation of QualiMed Mr. Guelcher worked as manager for quality and regulatory affairs at DEVON MEDICAL, Hamburg , Germany and as an auditor for medical devices at DEKRA (notified body), Stuttgart, Germany
Events
QualiMed will be participating at the following shows in 2011:
07. - 11. November 2011
TCT San Francisco 2011
Booth no. 733
http://www.tctconference.com
16. – 19. November 2011
Medica Duesseldorf
http://www.medica.de
12. – 14. January 2012
ASIA PCR Singapore 2012
Booth no. 13
http://www.asiapcr.com
25. – 28. January 2012
LINC Leipzig 2012
http://www.leipzig-interventional-course.de
Maps
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