Regulatory Pathways Assessment Guide
RPA PART
Completely free. No Commitments. This 17-page Regulatory Pathways Assessment guide (now updated with EU MDR requirements) is probably the most helpful tool I ever created.The RA part
Completely Free. No Commitments.
Regulatory Pathways Assessment Guide
This 17-page Regulatory Pathways Assessment guide (now updated with EU MDR requirements) is probably the most helpful tool I ever created. Hundreds of downloads later, I confidently assert the guide will help you work through project feasibility and requirements with FDA and notified bodies. And I promise I won’t spam you. Spam is a waste of everyone’s time. GET IT NOW!
Business Market Assessment Guide
BMA PART
Completely free. No Commitments. Regulatory compliance is a critical investment. Initial and recurring expenses take a big chunk out of your budget.The BA part
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 new 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.
QMSR Cheat Sheet!
QMSR PART
Completely free. No Commitments. This cheat sheet highlights the similarities and differences between the FDA's quality system regulation and ISO 13485 standards.The QMSR 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.
The Mother of All Flowcharts
SOP PART
Completely free. No Commitments. This is it – the Mother of All Standard Operating Procedure Flowcharts. It took quite a bit of effort to assemble. It’s yours, free.The RA part
Completely Free. No Commitments.
Regulatory Pathways Assessment Guide
This 17-page Regulatory Pathways Assessment guide (now updated with EU MDR requirements) is probably the most helpful tool I ever created.
Hundreds of downloads later, I confidently assert the guide will help you work through project feasibility and requirements with FDA and notified bodies.
And I promise I won’t spam you. Spam is a waste of everyone’s time.
The FDA Small Business Designation Guide
SBD PART
Completely free. No Commitments. There’s no doubt about it - bringing new technology to market is expensive. But fear not - we have some good news for you!The BA part
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 new 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.
The Biological Evaluation Plan Guide
BEP PART
Completely free. No Commitments. Even if another company is designing, making, and distributing your device – your quality system requirements apply to you.The QMSR 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.
The SOP part
Completely free. No Commitments.
The Mother of All Flowcharts
This is it – the Mother of All Standard Operating Procedure Flowcharts. This 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 It took quite a bit of effort to assemble this massive mother of a flowchart. And it’s yours, absolutely free. GET IT NOW!
FDA Pre-Submission Cheat Sheet
PRE-SUB PART
Completely free. No Commitments. This cheat sheet compares the FDA pre-sub program with other FDA programs to help you make the right choice for your product.
