#ISO 13485:2012 VERIFICATION#
#ISO 13485:2012 ISO#

#ISO 13485:2012 ISO#

ISO 13485- 8.3.1 Non-conforming material high volumeД¬ontract Manufacturer as Design Owner ISO 13485 Is the Design Service Provider required to be ISO 13485 certified?ДЇDA Submits to White House Plan to Harmonize with ISO 13485 ISO 13485 Calibration Requirements- Assess and Record validity Previous measuring resultsД¬an I make an exclusion of Design and Development in ISO 13485:2016 if my product is not regulated Gap Analysis Checklist for ISO 13485:2003 2012 Will EN ISO 13485:2012 be revised when ISO 13485 is reviewed? ISO 13485:2016 - Medical Device Quality Management Systems Nothing against that, and it's great from the point of view that you can maybe use the certificate on other regulatory systems, but again, formaly, only a certificate to EN ISO 13485 give a presumption of conformity. However, to simplify stuff (and get more money ) NBs, usually sells the idea that an EN ISO 13485 certificate is required.

#ISO 13485:2012 VERIFICATION#

What is required is to show conformity with the essential requirements.ДЇor EN ISO 13485:2012 (which corrects some of the linking problems with the presumption of conformity in older version), if you look into the annexes you will verify that only some clauses give presumption of conformity with some parts of the MDD.ДЎ - ask the manufacturer if they are using a standard to gain presumption of conformityДў - if so, they need to addres which standard it is (and if it's not an harmonized one, the standard cannot give presumption of conformity)Дў - for the harmonized standard, verify, in the annexes, which clause gives presumption of conformity with any essential requirement (or, in the case of EN 13485, to which part of Annex 2 the clauses give presumption of conformity)ДЈ - for those, verify that the manufacturer is is conformance with the clause of the standardД¤ - verify if there are any other requirements of the directive which needs another round of verification (for example, directive requirements which are not covered by the clauses evaluated) Click to expand.One of the main problems with this is : a 13485 certificate is NOT required to show compliance with the MDD.

Iso 13485:2012