New Mandatory Requirement for ISO Certifiers

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A new Mandatory Document (MD9) has been published. All ISO certification bodies issuing ISO 13485 certificates (under an IAF accreditation body) are required to apply MD9 to medical device manufacturer assessments starting July 2012. One requirement that may affect Manufacturer’s seeking ISO certification is an increase in the total duration of ISO 13485 audits. The details of this may be found in MD9 Annex D.

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