Demystifying Medical Device Compliance
Medical device compliance is hard....but not impossible. Here we share helpful resources to support your product development lifecycle.
General categories of software
Software as a medical device, clinical decision support software, software for health and wellness...wondering about the different categories of software and how they relate to medical devices? Learn the differences between these categories of software.
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FDA's New Draft Guidance for AI/ML - what's in it?
The FDA just released a new draft guidance about what to include in your regulatory submissions for artificial intelligence and machine learning-enabled medical devices. Here's what they expect.
Classifying Medical Device Software
There are several ways to classify medical device software.
Why medical grade is bare minimum
Medical grade is good, but it's not enough - figure out what materials testing you might need for your product.
What are the requirements for a software as a medical device?
Many medical devices developed today involve software in some capacity. What's special about medical device software?
How do you keep your investors at ease while communicating with the FDA?
How to communicate with investors about the ongoing FDA process.
What is an IDE and do I need one?
Wondering about Investigational Device Exemptions? How do you test your device before it's approved?
EUA is over - what does that mean?
What comes after the EUA?
How do I choose a sterilization technique?
Sterilization is an important way to ensure your medical device is safe, and there are multiple techniques available. Figure out which one is right for your device.
Wireless coexistence for medical devices
Wondering how wireless signals impact the functioning of your medical device? Check out this guide to wireless coexistence testing and requirements for medical devices.
Tips for 3D Printing and Medical Devices
Considering using 3D printing for your medical device? Be sure to keep these things in mind!
How NOT to hold a pre-sub
Are you familiar with the pre-sub process? Wondering what to expect from your pre-sub meeting?
Quality agreement versus business agreements
When you're interacting with suppliers, it's important to have both quality agreements and business agreements in place. Check out this guide to learn more.
Clinical Study before QMS?
Can I run a clinical study before I set up my Quality Management System?
I’m building a medical device. Do I *need* to do a clinical study?
Building a medical device and wondering if you'll need to perform a clinical study? Depends on your device and the claims you want to make - check out some tips in this article.
Most Common Reasons for Warning Letters
Wondering about Warning Letters? Check out this guide to learn more.
Software as a Medical Device versus outside software
Wondering about the difference between software as a medical device or software in your medical device? Check out this guide to learn some medical device software best practices.
Principles of document control
Some basic principles of document control for medical devices. How do you know you have the right version of the right document?
What is a Culture of Quality?
Instilling a culture of quality into your organization is essential to maintaining compliance. Check out this guide on how to create a culture of quality.
My product is Class I, do I still need a Quality System?
While there are some Class I devices that do not require a quality system, it's not that simple. Learn more about how to determine if you need a quality system for your Class I device.
Types of verification and validation testing
Curious about the differences between verification and validation testing? Check out this post to learn more.
How long does it take to get an IRB study approved?
Wondering how long it will take to your study approved by an Institutional Review Board?
Are you a Breakthrough product?
Should you apply for Breakthrough Designation for your product? Check out this guide to learn more about FDA's Breakthrough Designation program.
How long does it take to get a medical device approved?
Wondering how long it takes before you can sell your medical device? Check out this guide for some tips.
What is a DHF, and do I need one?
A Design History File is important for any medical device. Check out this post about what's required in your DHF.
Is my product a medical device?
There are a few things to consider when trying to determine if your product is a medical device or not. Check out this guide to learn more.
Key Questions When Developing Software as a Medical Device
If you're developing software as a medical device, check out this post to learn about important questions to ask before you start development.
Why Do We Start Compliance Early?
We do precompliance so we build the right product, the first time.
3D Printing - Will it Help or Hurt Your Device?
If you're considering whether or not to use 3D printing as part of your manufacturing process for your medical device, check out this guide to see if it's right for you.
Crash Course on Medical Device Compliance
Medical device compliance is hard, but not impossibleLearn the basics during this webinar.
The Compliance Journey, Part 2: Transitioning to Full Compliance
I’m ready for full compliance, how do I make sure I'm following all the regulations? Find out during this webinar event.
The Compliance Journey, Part 1: Precompliance
I have an idea for a new medical device... Where do I start?
Managing Quality With a Contract Manufacturer
The quality of a finished product is ultimately the responsibility of the medical device company. Find out how to navigate dividing up responsibilities with your contract manufacturer effectively.
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