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 … Read More

FDA ISO 13485 Voluntary Audit Report Submission

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FDA CDRH is kicking off their ISO 13485:2003 Voluntary Audit Report Submission Pilot Program June 5, 2012.  FDA wants to explore how they can leverage off of some of the ISO 13485 audits being conducted by ISO conformity assessment bodies. The premise of the 13485 Voluntary Audit Report Submission Program was based on an amendment to the law, which is … Read More