There are two different and traditional options for medical device manufacturers to get their projects manufactured. One has been to use a company based in the United States that also manufacturers the USA, and the other is to choose a company that is based in another country, but that offers medical device manufacturing services in Mexico.
Today, there is a third option for medical device manufacturers to consider. This includes medical device manufacturing that is completed in Mexico but is a part of a company that is an American business. In many ways, this offers the best blending of all possible benefits to the OEM, but it is important to do research and find the right contract manufacturing service.
Quality Control Guarantees
In choosing a company as a contract medical device manufacturer, quality control and proven quality standards that meet ISO 13485 standards, as well as FDA requirements, will be essential. Not all companies outside of the USA hold these certifications. It is important to realize that the certification is related to the specific location, and not a blanket certification for the entire organization.
Always verify that the location in Mexico is ISO 13485 certified. This is a simple step and can be completed with a quick phone call or by reviewing information on the contract manufactures website.
Experienced Engineering Services
An important part of any medical device manufacturing and one that will have an impact on approval of the design and the time from design to market is the effectiveness of the engineering and design component.
By utilizing a company offering medical device manufacturing, engineering, and product design and development services, your internal engineering and design team can collaborate with the process engineers, helping to enhance the process to provide the lowest cost, most effective production options.
