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Are you prepared to address the differences between ISO 13485:2003 and ISO 13485:2016?
With a greater emphasis on addressing regulatory requirements and using risk management to design your quality management system, ISO 13485:2016 has a new engine, but there are a lot of new and smaller moving parts as well.
This presentation was developed by the ISO 13485 Working Group of the International Accreditation Forum and was developed for the medical device regulators of the Asian Harmonization Working Party, who represent regulatory authorities from 30 nations, covering more than four billion citizens.
For that reason it was designed to be one of the most thorough assessments of the new standard, while focusing on the intent of those changes.