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What to Consider When Outsourcing the Manufacture of Medical Equipment Assemblies

For some producers in the medical industry, such as manufacturers of large, capital medical equipment, it may not be practical or possible to outsource the entire system. A medical device manufacturer can still benefit from outsourcing by selecting high level assemblies (HLAs) to outsource.

Here are five things to keep in mind when pursuing this approach:

  • Utilize a qualified contract manufacturer (CM). The CM should have a robust Quality Management System. Typically, companies will look for CMs that have facilities holding ISO 9001 and ISO 13485 registrations.
  • Provide clear, accurate documentation to the CM. It is vital that the manufacturing drawings, bills of materials (BOMs), work instructions, and test protocols are detailed and accurate. A joint review of all documentation by both parties before moving forward is critical; missing information, redlines, undocumented knowledge, and critical processes need to be captured.
  • Choose a CM with a well-developed supply chain and supply chain management system. HLAs for medical equipment are usually integrated from a diverse variety of components, and no CM can make everything. The ability to quickly, easily, and economically obtain required BOM components is key.
  • Establish responsibility for documentation control. In many cases, it makes sense for the CM to control the drawing package to update redlines, manage component issues, etc. Sometimes for regulatory reasons, the medical device OEM chooses to retain control over documentation. The most important thing is to define the scope of responsibility and ensure that procedures are clearly defined from the start.
  • Outsource assemblies at the highest level of integration possible. Outsourcing at the highest-level practical may simplify both the medical equipment manufacturer’s factory floor and supply chain. Place one purchase order and receive a fully-tested module ready to be integrated into the final assembly of your equipment.

By following these steps, you’re sure to enjoy a profitable relationship with your medical equipment assembly CM. Want to find out more about Keller Technology Corporation’s contract manufacturing services? Contact us today.

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Keller ISO Quality Management Certifications
Buffalo: ISO 9001
Buffalo: ISO 9001
Charlotte: ISO 9001, ISO 13485
Charlotte: ISO 9001, ISO 13485