Medical Device Design

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 clinician.

Services offered:

  • Medical device consulting
  • Design verification and FDA 510k submission
  • 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)
  • FDA registration
  • Manufacturing consultant
  • Medical device registration
As you define your design specifications, you also begin establishing production processes to support clinical studies and ultimately support regulatory submissions to governmental bodies.