Measurement Chip Detects Legionella

A new Microarray rapid test significantly speeds up detection of Legionella pneumophila outbreaks. It offers many advantages over conventional testing methods and the system can be deployed for environmental hygiene, as well as clinical diagnostics.

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Medizintechnik Zuliefererverzeichnis

Europas Markt für Medizingeräte und In-Vitro-Diagnostika

Adhesives are used in medical device manufacturing for creating bonds to join components and can be made from a wide variety of materials such as; acrylics, polyesters, silicones and urethanes. They may be set using light, moisture, or ultraviolet (UV) curing processes. Unique epidermal adhesives have been developed for wound care and epidermal drug delivery where exceptional considerations had to be made regarding biocompatibility, shelf life, sterility, adhesion and ease of removal and fluid resistance.

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Clean rooms are a purified, controlled environment used in manufacturing contaminant-free medical products. Clean rooms designated for the manufacture of Class I, II, or III devices are subjected to the strictest requirements regarding temperature, humidity, dust, airborne microbes, aerosol particles, and chemical vapor levels. Managing a contaminant-free environment requires dedicated sensors, control systems, HEPA or ULPA filters, circulatory and exhaust systems. Staff using clean room facilities are required to wear special garments, gloves and facial protection according to clean room class rating.

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State-of-the-art medical technology manufacturing facilities require computers, peripherals, related hardware, monitors and data storage devices or services. Seen as component, these can also be added into medical equipment or larger devices. Computer-aided design (CAD) and computer-aided manufacturing (CAM) and product-lifecycle-management (PLM) software are indispensable in the product development cycle. PLM, quality assurance/quality control (QA/QC), validation and verification software allow OEMs to ensure that their medical devices are safe and effective while being produced in compliance with regulatory standards. Medical device manufacturers require specialized software to develop products and manage operations.

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Medical device consultants are highly specialized and their services cover a wide-range of disciplines including, audits, device registration, QMS compliance, certification, regulatory, clinical trials, reimbursement, legal, inspections, in-country representation and qualifying potential distributors. Some medical technology consultants are expert in providing detailed market analytics in assessing a device’s market viability. Many suppliers to OEMs are also highly specialized in their fields and offer consulting services based around their core competencies.

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Electronics are key components in medical devices while electronic contract manufacturers and R&D services play a crucial role in medical technology development. Embedded systems, printed circuit boards (PCBs), sensors and power supplies are developed to fit the demands for smaller, portable devices or for point-of-care users. Demands for increased functionality place stress on electronic component suppliers to develop more efficient, compact systems. Typical electronic components include; cables, connectors, controls, displays, lasers, sensors, switches, transformers and wireless technology.

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Filters in the medical device industry purify air or fluids and protect patients from coming in contact with unwanted substances. IV filters are the most common filters in the medical device industry and are manufactured in a variety of materials. Catheters are medical devices that can be inserted in the body for disease treatments or to perform specific surgical procedures. Through engineering, material or manufacturing modifications, catheters can be customized for cardiovascular, urological, gastrointestinal, neurovascular, and ophthalmic applications. Essential components in drug delivery systems include; cannulae/needles, connectors, couplings, stents and valves.

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Medical devices often require hardware components and accessories to make them fully functional. Component suppliers generally carry standard items on stock and many are capable of providing custom components for specific applications. Medical components for OEM manufacturers can cover mobility requirements via casters, handles, shock absorbers as well as housing and coverings for equipment, as well as locks, hinges, latches and stoppers. Gaskets and seals provide solid fittings for two separate pieces of equipment that need to connect, while electric components allow for user interaction, monitoring and for controlling temperature.

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Producing a medical device requires the use of a wide variety of manufacturing equipment capable of processing ceramic, metal and plastic parts. Various automation apparatuses are used to process diverse materials, automate assembly lines and ensure the cleanliness and functionality of certain components while maintaining precise industry and engineering standards. Medical manufacturing systems can be required to cool, cure, cut, grind, heat, drill, laminate, machine and weld. Specialized machinery can manufacture a complete medical device to specific engineering demands while other equipment may support the manufacturing process with workstations, stairs and platforms, positioning arms, lamps and more.

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Medical contract manufacturing is an outsourcing service that may require the complete construction and distribution of a finished product or the fabrication of an element of a larger product. Some service providers offer complete outsourcing services from R&D and design through sales and distribution. Others are highly specialized in particular service areas such as assembly, cutting, converting, etching, joining, machining, moulding, sealing and welding. Medical contract manufacturers should meet CGMP standards or have ISO 13485 certification and, when required, cleanroom capabilities.

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Medical devices are comprised of a variety of organic and engineered materials and are chosen for a specific application based on their properties and performance characteristics. Whether ceramic, thermoplastic, engineered thermoplastic, elastomer, rubber, silicone, metal, alloy, textile or sponge, each material has its own distinct qualities which offers its own ideal application in the fabrication of medical devices.

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Stringent measuring, testing, and inspection must be conducted on medical devices and components to ensure compliance of quality and regulatory standards. Testing is required through the entire medical device creation, from design through the manufacturing processes, to analysis of the finished product. Some OEMs chose to have this done completely or partially in-house using measurement instruments, inspection and vision systems and testing equipment. Other OEMS may prefer to outsource some or all of their required services for clinical trials, biocompatibility testing, product safety, packaging, sterility and materials analysis or validation.

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Plastic injection molding may be used to manufacture a variety of components, from micro components to complete medical devices from single or multi-cavity moulds. Single and multi-shot and multi-shot liquid silicone rubber (MSLSR) plastic injection can produce simple and complex components. Typically, moulding service providers offer full services from design to production. Some moulders are highly specialized with core competencies that may include, injection molding, insert molding, overmoulding, micromoulding. Molding equipment is available to OEMs that decide to keep this process in-house.

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Motion control elements and motors enable movement of or within a medical product. A range of motor types can be found in full-scale diagnostic devices down to a compact, handheld surgical device and even in automated dosage machines for patient care. The most common medical motor categories include; ac, brush and brushless, dc, servo and stepper. The unique qualities of each motor type dictate their possible application in a medical device. Robotics and linear motion systems are common motion control components in medical device manufacturing processes.

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Reliable medical devices must be enclosed in tamper resistant, durable packaging in order to remain sterile, safe-for-use and regulatory compliant. Suppliers provide critical materials such as bags, films and foils, lids, moisture-barrier packaging options, pouches, roll stock, trays, wrapping. Packaging equipment and services may include bagging, blister packaging, crimping, form-fill-sealing, soldering, thermoforming, sealing, vacuum forming, and wrapping. Some specialized contract packagers offer a warehousing and logistic services.

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Manufacturers must consider the environment their product or product’s packaging information may be subjected to during packaging, shipping, storage and eventual use. Printing, bar-coding and labelling equipment are available for OEMs inteMTMEed in adding these systems to their in-house production process. Other OEMs outsource to companies specialized in full-service printing and labelling.

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Pumps and valves perform a variety of essential functions in medical devices. These functions include the dispensing and regulating flow rates of air, gases and liquids and are used in transporting medicine directly into a patient’s blood stream or to provide liquid nutrients. Suppliers in the medical device industry offer standard, on-stock pumps and valves and custom engineered solutions.

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Contract Research and Design (R&D) and design services play a key role in medical device manufacturing in the development stages of a product. Specializing in disciplines ranging from market research to design and process development. Design engineering companies offer in-depth, expert services for mechanical and electrical design requirements.

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Providing sterile, residue -free products in the medical device industry is a critical cornerstone in preventing the spread of illness or infections. Ensuring the sterility of an end-user product, whether a bandage, implantable device, swab, syringe or surgical tool, is essential to the products successful application. Sterilization can be achieved through equipment capable of performing electron beam (E-beam), ethylene oxide (EtO) and gamma irradiation processes. Outsourcing sterilization specialists can provide the same including, autoclave, process development, logistic and warehousing services.

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Many medical devices require surface modifications or enhancements before they can be applied as intended. Medical device or component surfaces are often coated to protect them from exposure to chemicals, fluids and microbes. Surface-treatment equipment is used to coat, deburr, etch, polish, or to clean residue from manufactured parts or to prepare a product’s surface for coating; these surface treatment services can also be outsourced.

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Most tubing intended for medical devices is composed of metal or, more often; plastics. Extruded medical-grade tubing made of fluoroplastics, PEEK and silicone tubing is an integral component for medical devices and can be found in anesthesia, catheters and IV applications. Tubing materials can be manipulated to create tubes with differing wall thicknesses, single or multi-lumen, braided or reinforced. Tubing suppliers may also offer tight tolerances and different augmentations, like antimicrobial finishes or additives that improve radiopacity. Tube processing systems may include; coiling, crimping, cutting, expanding, extruding, and tipping equipment.

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