Design Your Product

Translate customer requirements into design specifications. Create prototypes and formulations. Verify and validate your design.

With the product idea defined, you begin translating customer requirements into design specifications, creating prototypes and formulations, and verifying and validating your design -- all with the objective of creating a commercial product that can be consistently manufactured to address the needs of the patient and the clinician.


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
As you define your design specifications, you also begin establishing production processes to support clinical studies and ultimately support regulatory submissions to governmental bodies.

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