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Product showcase


■ 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


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


mdi Consultants www.mdiconsultants.com


Redefine the photochemical etching possibilities


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 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 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 Device Developments / www.nsmedicaldevices.com


Develop high- quality springs


Ming Tai Industrial is an expert in producing medical device springs.


Ming Tai Industrial is a professional manufacturer of steel strip springs for medical device applications; including constant force springs, constant torque springs, constant force springs for carbon brush, power springs and prestressed power springs, variable force springs and spring-strip tubes. Ming Tai has helped lots of medical device manufacturers successfully develop new products. All innovative products include a pen-type drug injector, highly adjustable monitor-and-keyboard- integrated medical workstation, highly adjustable patient bed trapeze, highly adjustable patient bedside table, Bowden cable for endoscopes and draw-wire encoder for MRT machines. The performance of Ming Tai’s steel strip springs and the company’s manufacturing service have gained much praise and appreciation from customers. Ming Tai is capable of providing customers with technical support during the development procedure and prototype, through to trial runs, mass production, spring mounting and assembly. Each manufacturing procedure, including steel strip slitting, heat treatment, edge trimming and forming process, is a consistent production and is completed in-house to ensure the highest quality is achieved. Ming Tai also has precision instruments to do force, torque


and product-life testing to ensure quality, and the company is certificated with ISO 9001:2008 and RoHs. There are a number of different spring design possibilities for a given application, and Ming Tai suggests consultation with one of its engineers early in the design phase. Ming Tai can to create an optimised solution for any spring demand. Custom designs are available as well.


Ming Tai Industrial www.powerspring.com.tw


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 up to 1,600°C and quantities from a few kilograms up to several thousand kilograms annually. Its unique in-house capabilities allow it to melt larger quantities in a variety of crucible types. Customers look to Mo-Sci when they need high- purity implant or medical-grade glass materials, or custom glass compositions specific to their application needs. Other service capabilities offered include glass analytics, coatings, spheroidisation and glass development.


Mo-Sci produces technical glass materials for medical devices.


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