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.
The QA Part Guide
THE QA PART
Completely Free. No Commitments.
QMSR Cheat Sheet
QSR? ISO 13485? QMSR?
This new regulation was along time coming, and it can be confusing to figure out how exactly what you need to do to keep your QMS – and your product – compliant.
This cheat sheet will help you navigate the similarities and differences between QMSR and ISO 13485.
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.
Mother of All Flowcharts 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.
Completely Free. No Commitments.
Small Business Designation Guide
THE SBD PART
Completely Free. No Commitments.
The FDA Small Business Designation Guide
There’s no doubt about it – bringing new technology to market is expensive.
But fear not – we have some good news for you!
If you are a small business with less than $100 million USD in annual revenue, you could save up to 75% on submission fees. All you have to do is file your application for a Small Business Designation each year with the FDA.
Sounds simple, but the process can be daunting, which is why we’ve put together this handy guide to help you through it. So download this guide, file your taxes, and pour your favorite drink – you got this.
You could save $18,000 on your 510(k) fee.
If you’re considering a Small Business Designation application, this 43-page presentation walks you through the steps.
Download it free – and if you need help, ask. 🙂
Completely Free. No Commitments.
The Biological Evaluation Plan Guide
THE BEP PART
Completely Free. No Commitments.
The Biological Evaluation Plan Guide
FDA has updated the ISO 10993-1: Biological Evaluation of Medical Devices companion guidance for the second time in four years.
That means BIG changes to the biocompatibility requirements for medical device submissions, especially if you are planning on leveraging data you already have in your next submission.
Keep your submission on track – and off the HOLD list – with our Biological Evaluation Plan template (BEP).
This handy template will help you navigate the changes and craft a biocompatibility plan that will answer the FDA’s questions before they ask.
Table of Contents
- Purpose
- Product Description
- Device Composition
- Clinical
- Indications for Use
- Contraindications for Use
- Intended Patient Population
- Device Information
- Relevant Product Information
- Device Categorization per ISO 10993
- Device Sterility
- Sterilization Information
- Biological Testing Checklist
- Test Articles
- Additional Information
- Appendices
Completely Free. No Commitments.
The Pre-Sub Part
THE PRE-SUB PART
Completely Free. No Commitments.
FDA Pre-Submission Cheat Sheet
This cheat sheet compares the FDA pre-sub program with other FDA programs to help you make the right choice for your product.
Grab this template!
For those of you with a device or other product in the pipeline, this cheat sheet will prove invaluable when determining your best path forward.
Use this easy template to identify the FDA program best suited for your needs, so you don’t waste time and money following the wrong advice.
Completely Free. No Commitments.
THE LABELING PART
THE LABELING PART
Completely Free. No Commitments.
Labeling Requirements Checklist
This checklist will help you create compliant labeling for all your devices.
Grab this template!
For those of you with a device or other product in the pipeline, this cheat sheet will prove invaluable when determining your best path forward.
Use this easy template to identify the FDA program best suited for your needs, so you don’t waste time and money following the wrong advice.
