Product showcase


and travel. The Spring- powered reels mount easily, come with pre-installed cables and attach quickly.


John Evans’ Sons is eager to discuss the design requirements and spring challenges in clients’ various design and prototype phases. Many choices of springs and reels are stock items that can be shipped quickly to aid in product evaluations.


John Evans’ Sons www.springcompany.com


Medical-standard welding


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 power measurement and pyrometer functionality.


The Leister Basic S is essential for effectively welding plastic components.


The new Basic S from Leister is the perfect integrable plastic laser-welding system for the medical industry. 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


Leister www.leister.com


More than just FDA regulatory assistance mdi Consultants has been in the regulatory business for over 43 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


Medical Device Developments / www.nsmedicaldevices.com


■ device listing and registration ■ US agent services for foreign companies


■ assistance with e-MDR ■ assist with the UDI for medical devices


■ FDA labelling guide reviews for food products, and dietary and nutritional supplements.


mdi Consultants www.mdiconsultants.com


Redefine the photochemical etching possibilities


in 3D within the thickness of the material itself. How about metal filters or sieves with conical holes that allow easy backflushing for cleaning? The company’s process can provide levels of precision and design freedom that are simply impossible with other production methods, such as laser cutting, stamping or electrical discharge machining, while offering high-volume production capacity and cost- efficiency. The company has years of experience in providing the most challenging metal components for medical devices and surgical


Micrometal’s photochemical etching process has pushed the boundaries.


As the world’s premier manufacturer of


photochemically etched metal components, Micrometal has consistently pushed the boundaries of what’s possible with chemical etching. The company’s unique variation of the photochemical etching process, which includes the use of an ultra-thin liquid photoresist and ultra-high- resolution photomask tooling, enables it to produce customised parts that would otherwise be impossible to manufacture. The continuous reel-to-reel etching line allows Micrometal to supply nearly endless strips of components that are ideally configured for integration into high-volume manufacturing lines, with each component being completely identical. If necessary, Micrometal can also provide individually packaged components that are ready for use. Imagine speciality surgical blades that are pre- sharpened directly from the etching process or lancets with specific features etched


applications. It can work with a variety of materials, including stainless steel, aluminium, copper and copper alloys. The Micrometal design team works with each client to fully understand the function and intent of their specific application, and design a customised solution that is the ideal combination of performance, cost, quality and ease of manufacturing integration. The company’s goal is to provide not only the best components possible, but also the ideal solution to every individual client’s requirements.


Micrometal www.micrometal.de/en


Medical-grade custom glass manufacturing Mo-Sci specialises in manufacturing technical glass materials, such as glass powders, microspheres, and ingots specifically designed and manufactured for the medical industry. Mo-Sci materials, like bioactive glass and precision glass microspheres, can be found in numerous medical devices on the market today.


The company has melting capabilities for temperatures


159


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