Start-up creation, location, and registration(s)

Technology assessment, intellectual property, and claims

Creation of a Scientific Advisory Board

Initial plan, timelines, and exit strategy

General funding assumptions and plan

Pitch presentations

Non-diluted and diluted sources 

General reimbursement plan

General goals, plans, and timelines

Resources for engineering and prototyping

Protocols, testing, and evaluations

User needs, ergonomics, and human factors

Regulatory plan and pre-submission preparation

Device classification, strategy, and opportunities

Regulatory compliance with FDA and Europe

Instructions for Use

General quality plan

Device history file and compliance with ISO standards

DFMA and CAPA

Manufacturing requirements

General pre-clinical plan review

Bench and pre-clinical testing and protocols

Good Laboratory Practices (GLP)

Analysis of pre-clinical results

General clinical plan review 

Pilot clinical evaluation protocols

Good Clinical Practice (GCP)

Analysis of interim and/or final results

Evaluation of unmet clinical needs

Questionnaires and surveys

Analysis of marketing assessment results

Review of marketing presentations and claims