Medical device developers have a big job. Not only is their product development complex, they also have to satisfy regulatory bodies, such as the FDA. And regulations only become more stringent as technology becomes more complicated.
As these changes occur, it’s important to have a handle on some basics.
This guide covers some common topics with which medical device developers should be familiar.
Read along or jump to the section that interests you most:
- Medical Device Compliance Basics
- 21 CFR Part 11
- FDA Medical Device Regulations
- Development Process for Medical Devices
Medical Device Compliance Basics
If you can’t prove compliance for your medical device, you can face any number of consequences, including fines, penalties, and product recall.
Regulations exist to protect us all. Here are three reasons why medical device compliance is so important.
Proving compliance is dependent upon on traceability. Learn about tracing requirements and automating manual processes.
5 Essential Traceability Components for Medical Device Development >>
It's also good to arm yourself with knowledge on specific regulations. We dive into 21 CFR Part 11 below. If you're a medical device software developer, you'll also want to know about the functional safety standard IEC 62304.
What Is IEC 62304? Compliance Tips For Medical Device Software Developers >>
21 CFR Part 11
21 CFR Part 11 is part of the code of regulations that fall under the FDA. It applies to electronic forms and signatures that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or any FDA regulation. Download these resources for help understanding how it impacts you:
Trends in Medical Device Development
Learn what challenges medical professionals identified in the State of Medical Device Development surveys.
FDA Medical Device Regulations
How to Get FDA Approval for Medical Devices
FDA approval establishes that your device is safe and effective. Approval involves proving compliance with regulations like 21 CFR. This guide covers:
- What you need to know about FDA approval vs FDA compliance.
- The individual parts of 21 CFR.
- The 5 steps to get FDA approval for your medical device.
FDA Design Controls: Plain & Simple Guide for Medical Device Developers
The design control process helps medical device developers manage quality, meet requirements, and prevent potential issues or recalls in the future. This guide explains how to accomplish design and development planning.
FDA Compliance and Medical Device Development Process
Learn more about how to meet FDA compliance standards for your medical device development process. Specifically, how to apply FDA compliance standards to the development process, including:
- Design input
- Design output
- Design review
- Design verification
- And more
How to Follow FDA Cybersecurity Guidelines
FDA cybersecurity guidelines for medical devices exist to ensure that medical devices are secure. This overview covers what the guidelines are, and explains FDA cybersecurity guidance for medical devices.
Development Process for Medical Devices
One of the biggest questions that medical device developers debate is whether it’s possible to use an Agile methodology when you need to prove compliance. Read how to adopt Agile and still satisfy FDA requirements.
Agile in FDA Regulated Environments >>
Regardless of your methodology, validation and verification are a major part of development. See what those processes look like for FDA approval.
Verification vs Validation: 6 Tips for Medical Device Development >>
Software developers gain numerous benefits from continuous testing. Likewise, medical device software developers can use static analysis for continuous compliance.
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