Originally Published MDDI March 2005

Guide to Outsourcing

In most cases, the virtual manufacturer is not doing the actual manufacture, but is providing the design idea and plans on selling the finished device. The following four subjects are a good starting place as each must be addressed with SOPs and related forms:

• Design controls and risk management.
• Supplier controls.
• Complaints, medical device reporting, and recalls.
• Management responsibility.

However, for the manufacturer to address these issues in a quality system, the following activities are also needed:

• Identification and traceability.
• Corrective and preventive actions.
• Document and data controls.
• Quality records.
• Training.
• Internal audits.

If a virtual manufacturer decides to handle the inventory and shipping of its devices to customers, the following SOPs should be used. However, even if inventory and shipping are contracted out, all of the following activities must be addressed in supplier controls and supplier contracts:

• Inspection and acceptance.
• Nonconforming product.
• Labeling and packaging.
• Storage and shipping.
• Environmental control.
• Statistical techniques.

The final responsibility for the activities described by these SOPs remains with the virtual manufacturer.

Copyright ©2005 Medical Device & Diagnostic Industry