Engineering Plans

Our Services

Our goal is to get good ideas to market faster and be a catalyst for ideas that put patients first. By optimizing the development process, our team is poised to efficiently take your idea from innovation to introduction. 

Investor Ready Package

Get investor ready with essential elements for the design and development of your medical device or app. These deliverables will arm you with the information you need to answer tough questions about budgets, timelines, and prototypes. You'll be one step closer to securing the financing you need to take your idea to market. 

Design & Development Plan

The D&D Plan is a living document that details the necessary steps to take your idea from a napkin sketch to the shelves. Here we identify key milestones, activities, and the responsible parties. This is the foundation to your design history file.

Renderings

They say a picture is worth a thousands words. We'll create photorealistic 3D computer renderings to showcase your idea to your investors. 

Regulatory Assessment

A regulatory assessment will give you and your investors a clear picture of what it will take to get your device and/or app FDA cleared. We'll identify the predicate device and required submissions, such as a 510(k).

3D Printed Prototypes

These form-fit rapid prototypes will leave you and your investors in awe. Hold it in your hand and pass it around so everyone gets an idea of the incredible idea you have in store. 

Development Support Package

Our team of experienced engineers will guide the management and coordination of all aspects of your product design and development. This includes but is not limited to:

> Front end concept development

> Computer aided design

> Customer discovery and validation

> Human factors usability studies

> Risk analysis

> Test protocols and reports

> Verification safety testing

> Biocompatibility testing 

> Shipping studies 

> Validation safety testing

> Regulatory submission

> Quality system management