Quality Systems ISO 13485:2016 edition has BEEN REAFFIRMED AND WILL NOT BE CHANGED BEFORE 2024. The 2016 version made changes to risk management expectations by increasing references to risk from two places in the previous edition to over 46 places in the document. Additonal changes to the standard will require companies to review their quality system and update it to get recertified within 2 years for those presently certified and 3 years for those who do not yet have certification. Among those countries requiring the use of ISO 13485 for medical devices sold in their country are Canada, the European Union, Japan, and Australia. The US FDA does not recognize or require ISO 13485, but has an alternative requirement in the Quality System Regulation, 21 CFR 820, which is similar to ISO 13485, and one quality system can be developed to meet both requirements.
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