1996908 Preview

BS PD ISO/TR 80002-2:2017

Medical device software-Validation of software for medical device quality systems

standard by BSI Group , 10/31/2017

View all product details

Most Recent

Track It

Language:
    • Available Formats
    • Options
    • Availability
    • Priced From ( in USD )
    • Secure PDF 🔒
    • 👥
    • Immediate download
    • $398.78
    • Add to Cart
    • Printed Edition
    • Ships in 1-2 business days
    • $398.78
    • Add to Cart
    • Printed Edition + PDF
    • Immediate download
    • $538.48
    • Add to Cart

Customers Who Bought This Also Bought

Identical Versions Available

 

About This Item

 

Full Description

BS PD ISO/TR 80002-2:2017 applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.

This document applies to
  • software used in the quality management system,
  • software used in production and service provision, and
  • software used for the monitoring and measurement of requirements.
It does not apply to
  • software used as a component, part or accessory of a medical device, or
  • software that is itself a medical device.

Cross References:
ISO/IEC Guide 51:2014 ED3
ISO 9000:2015
ISO/IEC 12207:2008 Ed 2
IEC 62304:2006/AMD1:2015
IEC TR 80002-1:2009
ISO 14971:2007
ISO 13485:2016
NIST 500-234:1996


All current amendments available at time of purchase are included with the purchase of this document.
 

Product Details

Published:
10/31/2017
ISBN(s):
9780580764257
Number of Pages:
94
File Size:
1 file , 3.8 MB
Same As:
ISO/TR 80002-2:2017
Product Code(s):
30251827, 30251827, 30251827
Note:
This product is unavailable in Ukraine, Russia, Belarus