ISO 13485:2016 — A Devicemaker’s Transition Guide

Quantity Discounts
1 - 2
3 - 4
5 - 6
7 - 9
10 - 9999

ISO 13485:2016
A Devicemaker’s Transition Guide

Do you know all the changes between ISO 13485:2016 and ISO 13485:2003?

Do you have the time to sit down and figure out clause-by-clause and line-by-line the differences between the two?

ISO 13485:2016 — A Devicemaker’s Transition Guide has done the work for you — saving you valuable time to make plans and put them in action. It has a clause-by-clause, line-by-line, 46-page comparison of the old and new versions of 13485 that shows you exactly what and where the new requirements are (click here for a sample).

In this management report you will learn:

  • The major differences between ISO 13485:2003 and ISO 13485:2016
  • The role of ISO 13485:2016 in the MDSAP and Canada’s plan to adopt it
  • The status of EN ISO 13485:2016 and issues related to the product directives
  • Some potential concerns related to ISO 13485:2016 and FDA’s QSR
  • How recent revisions to ISO 9001 compare to the new 13485

The report interprets the four key areas in the 2016 version — risk management, design control, supplier management and corrective and preventive action — and explains what kind of changes the new standard will require.

Based on the insight of one of the world’s foremost ISO experts, this report is essential for any devicemaker that hopes to survive the coming transitions. Order your copy of ISO 13485:2016 — A Devicemaker’s Transition Guide today.


PDF Edition

Available Format

PDF Edition — $397

 Who Will Benefit

  • Quality Managers
  • Quality Engineers
  • Quality Auditors
  • Regulatory Managers
  • MDR Handling Specialists
  • Complaint Handling Specialists
  • Risk Managers
  • Data Analysts

Multi-user Access

Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.

Our Guarantee

Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.