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.
