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Manufacture Your Product

Establish your medical product's Device Master Record or Master Manufacturing Record.

Design Controls establish your medical product's Device Master Record (DMR) or Master Manufacturing Record (MMR). The DMR or MMR captures all of the product specifications and manufacturing procedures needed to consistently produce your new medical product.


You must operate this manufacturing environment in a state of control that demonstrates that you are consistently producing your product, and that you comply with FDA Good Manufacturing Practices (GMPs) and ISO standards. To assure this state of control, you need to conduct internal audits. You will also be required to demonstrate this to 3rd parties like the FDA and Notified Bodies (certifications).

Services offered:

  • Design input and presubmission
  • Design verification and 510(k) submissions
  • Design validation and premarket approvals, humanitarian use device and exemption applications (PMA, HUD/HDE)
  • Technical file development (TF)
  • Clinical study design and management
  • Clinical evaluation reports (CER)
  • Quality system (QS) design and process validation

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