Premium Pre-Submission Package

$5,850.00

Our team at MIP has compiled our most useful resources and templates to help early stage medtech companies get started on their journey to FDA approval.

The premium pre-submission package includes:

  1. Substantial Equivalence Template

  2. Pre-Submission Project Plan

  3. Pre-Submission Meeting Minutes Template

  4. Indications for Use Template

  5. Pre-Submission Presentation Template

  6. Pre-Submission Issue Resolution Template

  7. Pre-Submission Application Template

  8. De Novo Considerations Template

  9. 513(g) Template

  10. Regulatory Plan Template

  11. 5 Hours On Demand Partner Support

Add To Cart

Our team at MIP has compiled our most useful resources and templates to help early stage medtech companies get started on their journey to FDA approval.

The premium pre-submission package includes:

  1. Substantial Equivalence Template

  2. Pre-Submission Project Plan

  3. Pre-Submission Meeting Minutes Template

  4. Indications for Use Template

  5. Pre-Submission Presentation Template

  6. Pre-Submission Issue Resolution Template

  7. Pre-Submission Application Template

  8. De Novo Considerations Template

  9. 513(g) Template

  10. Regulatory Plan Template

  11. 5 Hours On Demand Partner Support

Our team at MIP has compiled our most useful resources and templates to help early stage medtech companies get started on their journey to FDA approval.

The premium pre-submission package includes:

  1. Substantial Equivalence Template

  2. Pre-Submission Project Plan

  3. Pre-Submission Meeting Minutes Template

  4. Indications for Use Template

  5. Pre-Submission Presentation Template

  6. Pre-Submission Issue Resolution Template

  7. Pre-Submission Application Template

  8. De Novo Considerations Template

  9. 513(g) Template

  10. Regulatory Plan Template

  11. 5 Hours On Demand Partner Support