MPMN_Medical Product Manufacturing News

Medical Product Manufacturing News, March/April 2015

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BIomedevice Boston 2015 MPMN ANNIVERSARY PROFILES TH AVALON'S POLYMER SOLUTION CASTING Avalon combines polymer science, unique engineering technology and innovation to provide new and distinctive solutions for medical device companies. Customer ideas quickly take shape into robust, feature-rich, quality medical devices. Polymer solution casting methods allow us to incorporate materials with different properties – including strength, lubricity, flexibility and multi-lumens – for custom reinforced catheters, sheaths, shafts and assemblies. MANUFACTURING EXPERTISE AND STATE-OF-THE-ART FACILITIES Engineering expertise includes development, manufacturing, quality and material science. State-of-the-art manufacturing facilities are ISO 13485:2003 certified and FDA-registered. Avalon Laboratories, LLC MPMN ANNIVERSARY PROFILES TH Company Information Avalon Laboratories, LLC 2610 E. Homestead Place Rancho Dominguez, CA 90220 Phone: 310-761-8660 Fax: 310-761-8665 Web Site: www.avalonlabs.com See us at BIOMEDevice Boston Booth #825 IT'S WHAT'S ON THE INSIDE THAT COUNTS ® E L E C T R O N I C S C O R P. www.keyelco.com s (718) 956-8900 s(800) 221-5510 ™ INTERCONNECT COMPONENTS & HARDWARE Battery Clips, Contacts & Holders Fuse Clips & Holders Terminals and Test Points Spacers & Standoffs Plugs & Jacks Multi-Purpose Hardware Cleanroom Film extrusion A contract manufacturer of custom thin-wall medical device components, Polyzen Inc. offers among its cleanroom manufacturing operations flm extrusion in a Class 10,000 environment. This capacity supports prototype development and scale- up, as well as the production of flm for use in regulated wound-care, implantable, and other medical devices. The company can extrude flm up to 52 in. wide in thicknesses ranging from 0.0005 to 0.070 in., with in-line x-ray gauge dimensional reporting. Materials processed include thermoplastic urethanes, thermoplastic elastomers, polyolefns, polyamides, fuoropolymers, and bioresorbable polymers. The cleanroom, equipped with high- effciency particulate air flters, encapsulates the entire extrusion line. ■ Polyzen Inc. APex, NC www.polyzen.com Booth #544 Cybersecurity services The testing and certifcation organization TÜV Rheinland provides security consulting and remediation services for medical device manufacturers to help them fulfll the current FDA guideline on medical device cybersecurity. Assessment, testing, and remediation services are offered to help manufacturers analyze threats to and vulnerabilities within medical device software and communication systems. Vulnerability assessment analysis reveals how susceptible a device is to cybersecurity attacks from internal or external sources, and projects the outcome of such attacks. Penetration testing consists of manual attempts to identify, exploit, and penetrate the network, system, or application security vulnerabilities in order to obtain access to the medical device and associated data. Software source code analysis involves an application security assessment that uses tools and manual review to assess the application's security posture. Upon completion of these services, consultants provide advice on how device makers can remediate any security problems either on their own or with the test organization's assistance. ■ tÜV Rheinland BoxBoRoUgh, MA www.tuv.com/us Booth #1116

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