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.īased 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. How recent revisions to ISO 9001 compare to the new 13485.Some potential concerns related to ISO 13485:2016 and FDA’s QSR.

The status of EN ISO 13485:2016 and issues related to the product directives.The role of ISO 13485:2016 in the MDSAP and Canada’s plan to adopt it.In this management report you will learn: 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). 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. Do you know all the changes between ISO 13485:2016 and ISO 13485:2003?ĭo you have the time to sit down and figure out clause-by-clause and line-by-line the differences between the two?

Iso 13485 fda