Product showcase
power measurement and pyrometer functionality.
Leister
www.leister.com
The perfect material choice
The Leister Basic S is essential for effectively welding plastic components.
Incorporating a unique, state- of-the-art cooling system that was developed in-house, the Basic S is set to redefine the market. The permanent cooling of the laser ensures the precise and repeatable welding of plastic components. To ensure products can be welded in accordance with stringent medical industry requirements, the Basic S is coupled with powerful software that can record and output all welding- process data and parameters in a single file. Newly developed management profiles divide users into operator, expert and service categories. This critical feature secures parameters from alteration and accidental loss. All parameter changes are recorded and saved in a log. This feature makes it possible to track who accessed information, and where and when data for process modifications were initiated. A newly developed web- based human-machine interface (HMI) makes integrating the Basic S quick and intuitive. Digital as well as analogue signals are clearly displayed graphically and in real time. This new functionality makes it possible to detect which signals are on and off in the Basic S system at all times. Process parameters can be set using the web HMI or directly with the LCD display on the front of the system. The Basic S can be operated with the innovative, modular Leister laser optics. In contrast to the BT line, premium AT optics offer fibre connection monitoring, laser
valuable customer base in the field of sutures for heart valve manufacturing, cardiovascular and dental sutures, as well as new applications that are in discussion already. In the covered stent
Lenzing has developed an ePTFE tube for balloon expandable stents.
For more than ten years, Lenzing Plastics PTFE yarns are the material of choice for heart valve manufacturing and dental operations. Having achieved global coverage in all major markets, surgeons around the world are choosing not to return to alternative materials. Lessons learned in recent years were used to design a new, improved generation of Lenzing PROFILEN PTFE suture. The new generation is much more consistent in diameter – a weakness of PTFE as a polymer and its ways to be manufactured – which helps in needle attachment. Not only is the processing simpler but reaching a 1:1 ratio is also easier to achieve. In addition, the strength level was increased to improve the competitive advantage of higher knot-pull tensile strength at given diameter level. Finally, the manufacturing environment and technology have been improved to further reduce contact points and potential contamination. The rest of the environment was also improved in several ways to ensure Lenzing Plastics is set up for another decade of development and growth.
It continues to build its Medical Device Developments /
www.nsmedicaldevices.com
application area, Lenzing Plastics finished the development of an ePTFE tube used as cover on a balloon expandable stent. 4mm and a 3mm ID tubes are now available and further dimensions are set to be finished soon. When compared with bare metal stents, the area of peripheral stents is the first target market where PTFE is a well-known and used cover material to reduce restenosis rate.
Lenzing Plastics
www.lenzing-plastics.com
More than just FDA regulatory assistance mdi Consultants has been in the regulatory business for more than 44 years and has the expertise to provide exceptional professional aid in: ■ US FDA compliance, regulatory strategy planning, clinical trial development/ management, and QSR/CGMP compliance
■ MDSAP implementation and certification assistance
■ on-site audits – mock FDA and ISO performed by lead auditors and former FDA investigators
■ PMA/ANDA/NDA/510(k) application submission services – mdi has a 100% success rate over 4,000 FDA application approvals
■ FDA crisis intervention – 483 and W/L responses, third-party inspections and FDA mediation
■ electronic drug listing and registration with FDA
■ device listing and registration ■ US agent services for foreign companies
■ assistance with e-MDR ■ assist with the UDI for medical devices
The Helixa precision torque tester is ideally suited to measuring low and medium level torque on a variety of delicate or finely-engineered products.
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■ FDA labelling guide reviews for food products, and dietary and nutritional supplements.
mdi Consultants
www.mdiconsultants.com
Testing new generation
medical devices It is hard to over-estimate the importance of quality and reliability in the area of medical devices, since the lives and well-being of individuals are at stake and the industry is so tightly regulated. It is, therefore, a well-established area of standards and scrutiny. The global medical devices industry is extensive, and includes the simplest of mass- produced components to highly specialised one-off items and new materials development. With ever-increasing demand to drive down mass production costs and frequent introduction of new safety-oriented devices, it is essential that medical device manufacturers ensure quality throughout the design and manufacturing process.
Production quality guaranteed
Mecmesin force and torque test systems are ideal for testing the physical strength of all kinds of medical devices. Whether it is testing the glide force of syringes, the torque integrity of Luer connectors, the actuation force of drug delivery devices, the strength
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