Qualimed-Tsunamed: Implantable Medical Devices
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.
Development Expertise in Germany
Manufacturing is organized 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.
Up to date QualiMed has obtained CE approvals for more than 70 different products. QualiMed has developed over 4 Drug Eluting Stents of which it has two (2) CE approvals utilizing bio stable polymers and one more based on a proprietary fast absorbing biodegradable polymer coatings entering the commercialization phase.
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, and product diversification strategy.