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28 SMT Magazine • January 2016 important component in the design, prototyp- ing, and manufacturing process and one that, if done correctly, can save a considerable amount of time, money, and resources. By using an EMS provider that already has ISO 13485:2003 cer- tification, regulatory bodies know that certain procedures and requirements will be met, so certification is less labor-intensive and approv- als proceed more easily. Number 3: Location Check out where the EMS is located, where design and manufacturing are done, and make sure the size of the company is a good fit for your needs and products. Do you want the product manufactured close to where your company is located, close to where the product will need to be distributed, or are you manu- facturing large volumes where cost is a major factor so a low-cost geography might be more beneficial? Considerations in choosing a loca- tion are the complexity of the device, process transfer, IP protection, shipping costs and time, and the degree of involvement you will need throughout the process. Number 4: Service and Support One differentiator that is sometimes diffi- cult to discern initially is the degree and type of service and support you will receive. No matter what company you select, make sure that they consider each job they do to be spe- cial. Find out who your point of contact will be, who will be managing and supervising the manufacture and work, who will ultimately be responsible if changes need to be made or problems arise, and how they deal with these problems. Is the person you deal with a high level engineer? How much actual engineering support and trouble-shooting will be done to make sure your design will be able to be manu - factured accurately? The EMS should have the expertise to analyze your design for manufac- turability and potential problems, evaluate the bill of materials, and optimize the manufactur- ing process to find ways to produce the prod- top 10 FactorS to coNSider wheN SeLectiNg a medicaL emS compaNy feature