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Version is derived from the original bilingual publication by leaving out all French-language pages. Missing page numbers correspond to the Frenchlanguage pages. Reference number IEC 62304:2006(E) This is a preview - click here to buy the full publication INTERNATIONAL STANDARD IEC 62304 First edition 2006-05 Medical device software Software life cycle processes IEC 2006 Copyright - all rights reserved No part of this publication may be reproduced or utilized in any form or by any.

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single use devices (i.e. syringes, catheters) implantable (i.e. hip prothesis, pacemakers) imaging (i.e. ultrasound and CT scanners) medical equipment (i.e. anesthesia machines, patient monitors, hemodialysis machines)

Simply put, any software that helps to run a hardware medical device—say, by powering its mechanics or producing a graphical interface—is software in a medical device. Some examples include: Software that controls the inflation or deflation of a blood pressure cuff.

EHR is currently the most widespread type of software used in hospitals around the world. It is an efficient modern alternative to hand-written charts that allows hospitals to store information in a more organized and secure way.

Examples of software as a medical device (SaMD) Software that evaluates MRI images and makes diagnosis recommendations. Software that controls an MRI machine (SiMD). A mobile app that monitors a patient's heart rate or glucose levels and makes treatment recommendations to the patient and/or patient's doctor.

SaMD: Operates independently from any hardware, fulfilling its intended medical functions through software alone, typically on general computing platforms. SiMD: Integrates with other medical devices, requiring hardware to perform its functions.

Medical device software and risk management Having a quality management system (QMS) is a requirement of the IEC 62304. The most common standard used to establish the QMS would be the ISO 13485.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232