QualiMed was found in 1997 as an OEM manufacturer for implantable medical devices with a focus on the development and regulatory 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 removable pulmonary, esophageal, and biliary stents. In the last two years QualiMed started with the development of various biodegradable technologies, drug device combination products, and orthopedic implants as part of its diversification strategy.
Up to date QualiMed has obtained CE approvals for more than 70 different products. QualiMed has developed over 5 Drug Eluting Stents of which it has three (3) CE approvals utilizing bio stable polymers and two more based on a proprietary fast absorbing biodegradable polymer coatings which (1) has obtained CE approval and is entering the commercialization phase. The company also has a number of the products with both CE & FDA approval and is the current sole source manufacture of these technologies.
Manufacturing is organized in the plant outside of Hamburg Germany in the town of Winsen where QualiMed runs two Class 10,000 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 and holds more than 70 patents and utility models World Wide.
Company’s Keywords:
cardiology, peripheral vascular, non vascular, biodegradable
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