We’ve been through the process countless times.
If we can give you any advice it would be this: The only way to de-risk your company and get to market with the safest product possible is to dot your i’s and cross your t’s.
If we can give you any advice it would be this: The only way to de-risk your company and get to market with the safest product possible is to dot your i’s and cross your t’s.
Lucky for you, we are proud “i”-dotters & “t”-crossers!
Not only do we ensure that no stone is left un-turned as we guide you through the process, we’ll actually bully you to do it the right way even when you think it’s unnecessary! This is because our priorities are your success, as well as the well-being of the end users.
Flat-fee Pricing
Our flat-fee pricing ensures that our interests are aligned, so we are free to take whatever actions are necessary at each step to achieve our shared goal.
Phase.1
Your Genius Launch Plan
Shift from regulatory exhaustion and confusion to knowing exactly what to do to successfully develop and launch your most needed genius medical solution.
Every client starts with the Genius Launch Plan, a deep-dive into where you are in the product development life cycle—from the design, process, regulatory, risk management, verification & validation perspectives.
Based on our findings we will give you a step by step plan for your best course of action to successfully navigate the compliance process and achieve a high quality product launch. With this plan alone you will be better positioned for success than without it.
~4-5 Weeks
Starts at $6,660
Phase.2
Your Genius De-risked
Reduce regulatory and quality risks from day one, allowing you to save money, save time, and successfully product launch.
Based on the Genius Launch Plan, we will map out a detailed regulatory strategy to get your product to market. The Gap Analysis derisks your company’s future by ensuring compliance so you are cleared-approved by the FDA, as well as catching problems that can lead to expensive FDA violations down the line.
~1-2 Months
Starts at $16,999
*(based on findings in Phase 1)
Phase.3
Your Fully Shielded + Compliant Genius
Be bulletproof to FDA violations and recalls!
Based on the plan from Phase 2, we are here to implement the entire process with you: developing a robust Quality Management System (Product Development Design Control Process), including training, while ensuring your R&D efforts do not stop.
At the end of this phase, you will have the robust infrastructure needed to develop a safe + effective device that successfully gets to market, generates revenue, and save lives.
~3-9 Months
Starts at $49,999
*(based on findings in Phase 2)
In addition to taking startups through our 3 phase process to build their compliance foundation, we also offer healthcare Fortune 500 companies and Government Entities with the following services:
REGULATORY & QUALITY
Pre-Submission Meetings with FDA:
Communicating with the agency as early as possible results in the best final outcome ONLY when you are well prepared.
Regulatory Plan & Strategy:
When done correctly, this becomes your competitive advantage!
Regulatory Submissions and Applications:
For example, an Investigational Device Exemption (IDE) application is required for your investigational device to be used in a clinical study in order to collect safety and effectiveness data. A 510(k), De Novo, PMA (Premarket Approval), among other pathway submissions are required to acquire FDA approval or clearance to market your product in the US.
Product Registrations:
All medical devices sold in the US must be registered with the FDA
Quality Management System:
Most medical devices require a QMS (21 CFR 820; ISO 13485:2016), and they are not one size fits all.
We also implement QMS ISO 9001:2015
TECH REGULATORY DUE DILIGENCE *(For Investors)
We evaluate your next investment and give a detailed report on risk and opportunity.
“We enjoyed working with Ediuska and Genius Shield to build our company's regulatory and quality systems, and are now confident in our ability to deliver high quality medical products. With the Genius Shield team's expertise, we were able to lay the groundwork for our product development life cycle and quality management system. Ediuska was well organized and attentive to our needs during the various phases of product development. We're grateful to have had them as a partner."
— Sona Shah, CEO
and Co-founder of Neopenda.
and Co-founder of Neopenda.
