Completely Free. No Commitments.
Regulatory Pathways Assessment Guide
Completely Free. No Commitments.
Regulatory Pathways Assessment Guide
I’m glad you found your way to this page.
This 17-page Regulatory Pathways Assessment guide (now with EU MDR requirements) might be the most helpful tool I’ve ever created.
Hundreds of downloads later, I confidently assert the guide will help you work through project feasibility and requirements.
You’ll find there are many moving parts.
You’re going to want some help. Trust me on this.
So go ahead. Indulge. It’s free. No commitments. Nada.
Table of Contents
- Purpose
- Description of the Device
- FDA Device Classification
- Possible FDA Product Codes
- Differences Between Available Classifications and [Your Device Name]
- Possible Predicate Devices
- Tool to Determine Risk/Benefit Profile
- Registration, Listing and QMS Requirements Prior To Commercialization
- Submission Options
- De Novo
- 513(G) Request for Information
- Pre-Sub Meeting
- Applicable Standards and Test Methods
- Applicable FDA Guidance Documents
- Conclusions and Recommendations
Completely Free. No Commitments.
Business Market Assessment Guide
Completely Free. No Commitments.
Business Market Assessment Guide
Regulatory compliance is a critical investment. Initial and recurring expenses take a big chunk out of your budget.
Is it worth it? Only you can answer that question, but we can help.
Our market assessment tool walks you through the revenue vs. cost modeling calculations that can help you judge the market viability of your product – before you commit.
Table of Contents
- Purpose
- Market Overview
- [Table] Sales
- [Table] Based on Annual Device Usage
- [Table] Based on Annual Clinical Incidence
- Cost Considerations
- [Table] Cost Considerations by Geographical Region
- Deciding Into Which Geographical Regions to Market and Sell
- [Table] Proforma
- Conclusions
Completely Free. No Commitments.
Regulatory Pathways Assessment Guide
THE QA PART
Completely Free. No Commitments.
21 CFR 820 Roles and Responsibilities Guide
“The buck stops here.”
Even if another company is designing, making, and distributing your device – quality management system requirements apply to you.
Authority over your device cannot be outsourced.
This 21 CFR 820 Roles and Responsibilities Guide is a tool to identify who’s responsible for what. Attach it to your quality agreement!
Grab this template!
For those of you who outsource, this roles and responsibility guide will prove invaluable.
Use this easy template to identify and document who’s doing what – and what your regulatory obligations are – depending on your device classification, so nothing falls through the cracks.
Completely Free. No Commitments.
Regulatory Pathways Assessment Guide
Mother of All Flowcharts
Download these Mother of All Standard Operating Procedures (SOP) Flowcharts.
It took quite a bit of effort to assemble. It’s yours, free.
The four-page flowchart illustrates where design control, risk management, and usability engineering processes interact.
It pairs each of the five major project phases with the appropriate procedures and forms you’ll need:
Project phase 1: Planning
Project phase 2: Design and Development
Project phase 3: Design Verification
Project phase 4: Design Validation
Project phase 5: Design Transfer to Production
Grab this template!
So go ahead. Indulge.
Download it for free – and let me know if/how my team can help you get to market faster, better, and less expensively than you could on your own.
The Mother of all SOP Flowcharts!
I’m glad you found your way to this page for this:
the Mother of All Standard Operating Procedure Flowcharts for design control, risk management, and usability interfaces.
The four-page flowchart illustrates where design control, risk management, and usability engineering processes interact.
It pairs each of the five major project phases with the appropriate procedures and forms you’ll need:
- Project phase 1: Planning
- Project phase 2: Design and Development
- Project phase 3: Design Verification
- Project phase 4: Design Validation
- Project phase 5: Design Transfer to Production
So go ahead. Indulge. Download it for free – and let me know if/how my team can help you get to market faster, better, and less expensively than you could on your own.
