You want some medical device prototypes or low-volume production parts to verify the design structure, materials or even your whole medical device idea? Or your medical device development is stalled because the structure of low-volume parts is too complex to be CNC machined or injection molded? When you meet those problems in developing medical device components, you are highly recommended to leave it to the pros by finding a suitable and expert manufacturing supplier to solve all your problems. How to find the right medical device manufacturing supplier? The following may help you filter the suitable one.

►High-mix, Low-volume Manufacturing Service
Are you trying to create the high-quality medical parts for various testing, new product introduction? Usually, the quantity requirement for medical device components during development stage is relatively lower, however the parts are various in types, structures, and materials. A high-mix, low-volume manufacturing supplier will seamlessly meet your needs. Ranging from a few parts to batch production, on-demand production supplier with multiple manufacturing processes is able to support your medical device dedevelopment om prototyping to end-use production.

►DFM Analysis Service

Undoubtedly, the medical device development is accompanied by numerous verifications for part design. The qualified development partner should offer in-house design analysis, which will help optimize design according to manufacturability and future mass production. The ultimate goal of DFM analysis service is to make you find the defects of design and risks in mass production in the early stage of development and reduce the production cost and time. A manufacturing partner without DFM analysis service should be crossed out of your list.

Material Selection
The materials that you use for your medical device components are crucial. In fact, a certain percentage of medical products recalls are materials related. To avoid the unnecessary loss, you’re suggested to choose the manufacturing supplier with quality control procedure for incoming materials. In addition, the expertise in integrating appropriate materials and the ability of processing medical-grade materials should be noticed when choosing the manufacturing supplier. Especially the simulated materials with true material performance will be used during development stage to support the medical prototypes verification, your manufacturing supplier should be equipped with the expertise and experience to ensure that your materials are most optimized and qualified.

►ISO Certification

ISO certification certifies that a management system has all the requirements for standardization and quality assurance, and ISO 9001 is one of best-known standards, which defines the criteria for management principles. Company applying ISO9001 is the critical line of your selection. ISO 13485 certification is the quality management compliance standard for the medical device industry. The manufacturing suppliers who have the certification will readily provide the certification to convince you that their management system is complied with international standard. Companies certified with both ISO 9001 and 13485 are the preferred choice.

The Experience of the Team
The experience matters, especially in the manufacturing industry. A team with extensive experience and expertise in a similar industry will soon find the solutions to your problems, and even find out the potential risks in the early stage of your product development, reducing the cost and time in mass production. This is an invaluable consideration for your entire product development life cycle.


With high-mix, low-volume manufacturing services, RPWORLD has been providing customized production for medical device parts, including optical imaging equipment, diagnostic equipment, element analyzer, exoskeleton assisting components, medical ventilators, and clinical testing equipment, etc. CONTACT US to get free DFM analysis and start your next medical device project now.

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