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'An Unnecessary Editorial Revision': In Letter, MDSAP Council Rails Against ISO's Push To Change 13485 Quality Standard

06 Nov 2018

• By Shawn M. Schmitt

The chair of the Medical Device Single Audit Program (MDSAP) Regulatory Authority Council is warning of "instability" in industry if the International Organization for Standardization (ISO) Technical Management Board has its way and makes changes now to international quality systems standard ISO 13485.

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In a stark warning to the International Organization for Standardization (ISO), the head of the group that oversees the Medical Device Single Audit Program (MDSAP) says "instability" could come to the device industry if international quality systems standard ISO 13485 is retooled right now.

In a Nov. 5 letter, David Boudreau – chair of the MDSAP Regulatory Authority Council (RAC) – says a...