FDA-DESIGN › Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff

FDA-DESIGN - 2017 EDITION - CURRENT
Show Complete Document History


Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff


This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

 

Customers who bought this document also bought:

BS-EN-ISO-13485
Medical devices. Quality management systems. Requirements for regulatory purposes

UL-2900-2-1
Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems

IEC-60529
Degrees of protection provided by enclosures (IP Code)

ORDER

Price:

$20.00        




Document Number

FDA-DESIGN

Revision Level

2017 EDITION

Status

Current

Publication Date

Sept. 6, 2017

Page Count

21 pages