Product showcase Custom-
manufactured radiopaque clad wires
Anomet’s clad composite wires offer an alternative to typical medical wires.
Anomet Products has introduced custom-manufactured clad composite wires − an effective alternative to solid precious- metal wires with marker bands − to improve the visibility of implantable devices. This clad wire is a proven alternative to wires typically used in medical disciplines, such as: ■ Cardiac rhythm management (pacing and defibrillation)
■ Neurostimulation ■ Vascular therapy (stents, catheters and guidewires)
■ Biosensors ■ Monitors
Anomet radiopaque clad wires allow original equipment manufacturers (OEMs) to specify the degree of visibility they desire under fluoroscopy, by selecting the radiopaque alloys and cladding thickness best suited to their products. Easier to see than solid wires with marker bands, they are offered in sizes between 0.05mm and 1.52mm (outside diameter) for use with stents, guide wires and related devices.
Featuring platinum-iridium, tantalum and tantalum- tungsten alloys, as well as similar alloys metallurgically bonded to high-strength wires, such as 316LVM stainless steel, nitinol and MP35N with cladding thickness of 2% or higher, Anomet radiopaque clad
wires have a smooth, consistent finish. They are supplied on spools and manufactured to precise OEM specifications. Anomet is well known as a leader in innovative composite metal products. Founded in 1976, it specialises in the manufacture of custom- clad metal composites featuring a true metallurgical bond. The company is dedicated to developing new products using advanced metallurgical technology, resulting in long- lasting, reliable and cost- effective materials. With material costs today representing 90% of the overall cost of products, Anomet specialises in helping reduce costs, while improving material properties and quality. Producing clad wire, rod, bars, ribbons and plates, Anomet offers a wide range of metal alloy compositions that are available with virtually any ratio or thickness. The major industries the company serves include aerospace, automotive, appliance, corrosion protection, defence, electrochemical, electronic, industrial, medical, and oil and gas.
Anomet Products
www.anometproducts.com
Expert medical seals for life- saving devices
From the most exotic sealing devices to micro-miniature shapes, Apple Rubber can custom design medical seals to match any shape or size. It provides sealing solutions for a wide variety of applications, including ventilators, medical pumps, IV components, medical testing consumables and implant materials.
Effective medical seals require the right material to handle the task. Apple Rubber’s medical grade elastomers are tested to FDA USP Class VI or ISO 10993 protocols to meet regulated standards. As an extra precaution, the company’s polymer chemists will review the material selected to assure it meets full biocompatibility for the application. Its most common medical grade elastomers include Liquid Silicone Rubber (LSR), Viton Fluoroelastomer (FKM) and Ethylene Propylene (EPDM). Every medical seal is
designed to meet strict quality standards. Apple Rubber’s Class 10000, ISO 7, certified cleanroom is equipped to manufacture and package medical seals in a sterilised, controlled environment. If required, Apple Rubber engineers can provide specific quality documentation from First Article to full IQ OQ PQ. Apple Rubber design
Apple Rubber provides expert engineering to deliver medical seals for critical applications.
With 50 years of expertise, Apple Rubber has the experience, creativity and capabilities to design and manufacture medical seals for life-saving applications.
Medical Device Developments /
www.nsmedicaldevices.com
engineers work with customers from prototype to production to ensure every product meets exact specifications. The advanced 3D CAD and CAM technology allow the company to provide custom in-house tooling for medical seal design and prototyping. With versatility to assist at any stage – from concept through seal validation – Apple Rubber engineers develop strong, reliable medical seals that are able to withstand critical environments.
Apple Rubber
www.applerubber.com
Corrective and preventive actions in
CAQ.Net
CAQ AG’s company headquarters in Germany
The concept of Corrective and Preventive Actions (CAPA), required by GMP and numerous ISO/FDA regulations such as ISO 13485 and FDA 21 CFR 820, is a key method of quality assurance in the medical device industry.
CAQ.Net software solutions allow you to put into place a comprehensive CAPA- system in your company, with which you can identify possible causes for quality defects that have occurred, then solve them and adjust workflows, products, or manufacturing processes to prevent the defect from reoccurring. However, the software facilitates much more, as it allows you to not only carry out CAPAs, but also puts a global tool at your disposal with which you can monitor, control, and document your entire quality system – so that the reasons for a possible CAPA can be eliminated as best as possible in advance. The software provides various techniques for different facets of quality management and consists of all components that are necessary to monitor and document the quality of your products.
Thus, in the event of a
CAPA, you can access all quality-related data of a product with just one system and identify the true causes of a quality defect by means of comprehensive root cause analysis. Whether the root cause of the quality defect lies in the purchased raw material,
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