The essential IEC 62304 checklist
Is your medical device software audit ready?
Medical device approval can take up to 30 months, depending on the market and device class.
The last thing you want is your device’s software to be the reason it doesn’t gain approval during an audit.
Knowing the audit readiness of your device’s software can help you decide early on if your team needs to take steps to remedy any weaknesses and what those steps might be.
Whether you’re new to software or new to compliance in our checklist, you’ll learn about:
• Which are the early signs that your software is not audit ready.
• The risks and opportunities IEC 62304 presents to your software team and business.
• How to encourage documentation that’s an asset to your device software team
“This little book speaks directly to the needs of busy medical product development people who want to be more agile, and it speaks in plain language.”
– Nancy Van Schooenderwoert
Agile Consultant and co-author of the book series Agile Methods for Safety-Critical Systems
“Bluefruit Software has provided a guide that covers the important areas, is easy to digest, and serves as a useful introduction to the full standard.”
– Brian Shoemaker, Ph.D.
Software quality consultant to medical device companies and co-author of the book series Agile Methods for Safety-Critical Systems