OEM is a new offering from QualiMed providing internally developed products using the same high quality advanced design, development, and manufacturing standards that are a trade mark for the companies’ products world wide to customers globally. These products are designed and developed at our facilities with input from a variety of customers and our esteemed clinical advisors to provide our customers with mechanical implantable devices, catheters, and an assortment of technologies in their finished form for private label to our customers’ world wide.
QualiMed was found in 1997 as an OEM manufacturer for implantable medical devices with a focus on the development, production and regulatory approval of coronary stents and the respective delivery devices. Later the business was expanded to peripheral vascular and non vascular implants that included the worlds 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 orthopaedic implants as part of its diversification strategy. Up to date QualiMed obtained CE approvals for more than 70 different products mainly for stents and stent delivery systems and is the holder of more than 70 patents and utility models and offers its IP expertise in this area to protect customer ideas.
QualiMed utilizes its strong expertise in regulatory and quality processes to enable the company to CE certify the developed products and “transfer” CE to the customer based on established processes which have been successfully done for dozens of customers.
In the area of manufacturing QualiMed developed a lot of technologies for in-house processes:
All manufacturing processes are focused on customisation which is not limited to the above mentioned technologies and processes but includes for example customised labelling and packaging of the products as well as support for designing the Instruction for Use and marketing.
Manufacturing is organised in a plant in the south of Hamburg Germany in Winsen where QualiMed owns an area of more than 16,000 m2. The plant area of 3.000 m2 includes manufacturing in non controlled and controlled levels as well as Clean Room level.
QualiMed runs two clean rooms Class C (10,000) according to MDD (Medical Device Directive) and GMP standards. The second clean room was implemented 2 years ago when QualiMed started to develop and build Catheters for stent delivery systems (balloon expandable and self expandable) as well as PTCA and PTA catheters. Nearly all manufacturing and laboratory equipment including all testing and validation equipment was developed and built in-house.
QualiMed is offering a variety of products for private label in the areas of mechanical and catheter based technologies. We provide the devices fully assembled and available for shipment in bulk or we can provide the devices packaged and sterilized based on your unique container design and marketing requirements. Additionally we will provide component devices in the form of finished stents and catheters
Product Available
Stent Systems
Coronary Stent Systems
(Stainless Steel, Cobalt Chromium, Drug Eluting)
Peripheral Vascular Stent Systems
(Balloon Expandable & Self Expanding)
We offer a full range of compliant and semi compliant balloons for coronary, peripheral vascular, and non vascular procedures including interventional urology, gastroenterology, and urologic procedures.
Catheter
A large variety or approved catheters are available for use by our customer partners.
Balloon Blowing:
A full range of Compliant and Semi-Compliant balloons arre available based on our modern, controlled and validated blowing process.