ISO accreditation's a big deal, and by no means a formality ( have just gone through ISO process personally/corporately)
do not forget ISO stands for INTERNATIONAL standards organisation - with emphasis on INTERNATIONAL- once you have this, any national standards AUS/NZ for example are a formality.
I was curious about some of the wording in the ANN where reference was made to UK and Netherlands ? cannot see why just these two countries mentioned - would there not be more impact if the same data was repeated ( in table format) which would apply to ALL target markets? That would raIse some eyebrows
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- Ann: ResApp Clears Major Milestone for CE and TGA with ISO 13485
Ann: ResApp Clears Major Milestone for CE and TGA with ISO 13485, page-24
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