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26 SMT Magazine • January 2016 by Mo Ohady and David Estes DigicoM ElEcTronicS What makes for a successful contract elec- tronics manufacturing relationship and what does a medical device company need to keep in mind and consider during the selection pro- cess? Once the decision has been made to use an electronics manufacturing services (EMS) company, selecting the right one involves sev- eral steps. Although most EMS companies per- form the same basic services, every EMS compa- ny is different. You can tell when you walk into a place, examine the equipment and processes, and speak to the people. number 1: Prepare a List of requirements The initial basis for narrowing down your selection is to prepare a list of the basic require- ments you expect an EMS provider to meet and detail specifically what you want the EMS to do—design, prototyping, material selection and purchasing, manufacturing, test, process validation, shipping and logistics, etc. Do you need manual or automated processes, small quantities or volume manufacturing? Is the EMS able to offer the range of services that meet your needs? number 2: Certifications Does the EMS provider have the appropriate quality certifications to manufacture the prod- uct? There is no room for error with medical de- vices. A basic requirement for the medical mar- ket is ISO 13485:2003, the medical device man- ufacturing certification. This certification states the requirements for a comprehensive manage- ment system for the design and manufacture of medical devices, ensures that medical devices meet customer and regulatory requirements, and establishes a commitment to quality. The FDA's Quality System Regulation 21 CFR (Code of Federal Regulations) 820 requires medical de- vice manufacturers to perform a process valida- tion when the process is not fully verified by a subsequent inspection or test. Process valida- tion ensures that a process consistently produc- es a product that meets its specifications. It is an FEATurE

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