7.5.2 AO requires competence to verify appropriateness and validity of evidence X (IMDRF-N3) provided by subcontractor 7.5.3 Contractual arrangements between the AO and the subcontractor, including X (IMDRF-N3) clause for witnessed audits by RA. 7.5.4 Auditing Organization responsible for ensuring that all individuals within (IMDRF-N3) an outsourced organization that are involved in a regulatory audit are X directly assessed by the Auditing Organization to ensure consistency with the IMDRF MDSAP WG N3 and N4 requirements. 8.0 Information requirements 8.1 Publicly accessible information 8.1.1 Publicly accessible information X 8.1.2 Information provided by AO (including advertising) not misleading X 8.1.3 Publicly accessible information certificates granted, suspended or X withdrawn 8.1.4 to confirm validity of certification X 8.2 Certification documents 8.2.1 Means to provide certification documents to certified clients X 8.2.2 Effective date shall not be before the date of certification decision X 8.2.3 Details of certification document content X 8.2.1 Audit reports and certificates conform to RA requirements X (IMDRF-N3) 8.2.2 Certificate must reflect the scope of the audit, including regulations covered. X (IMDRF-N3) Certificate shall not exclude part of processes, products or services from scope of certification 8.3 Directory of certified clients. X 8.3.1 AO compliance with RA requirements related to publicly accessible X (IMDRF-N3) information 8.4 Reference to certification and use of marks (title only) 8.4.1 AO policy governing any mark it authorizes certified clients to use. X 8.4.2 AO shall not permit its marks to be applied to laboratory test, calibration or X inspection reports. 8.4.3 AO’s requirements of the client medical device manufacturer regarding X reference to certification. 8.4.4 AO ownership of marks and reports and control of use and references. X 8.5 Confidentiality 8.5.1 Policy and arrangements to safeguard confidentiality X 8.5.2 Inform clients in advance of information to be placed in public domain X 8.5.3 Written consent to release information X
7.5.2 (IMDRF-N3) AO requires competence to verify appropriateness and validity of evidence provided by subcontractor X 7.5.3 (IMDRF-N3) Contractual arrangements between the AO and the subcontractor, including clause for witnessed audits by RA. X 7.5.4 (IMDRF-N3) Auditing Organization responsible for ensuring that all individuals within an outsourced organization that are involved in a regulatory audit are directly assessed by the Auditing Organization to ensure consistency with the IMDRF MDSAP WG N3 and N4 requirements. X 8.0 Information requirements 8.1 Publicly accessible information 8.1.1 Publicly accessible information X 8.1.2 Information provided by AO (including advertising) not misleading X 8.1.3 Publicly accessible information certificates granted, suspended or withdrawn X 8.1.4 to confirm validity of certification X 8.2 Certification documents 8.2.1 Means to provide certification documents to certified clients X 8.2.2 Effective date shall not be before the date of certification decision X 8.2.3 Details of certification document content X 8.2.1 (IMDRF-N3) Audit reports and certificates conform to RA requirements X 8.2.2 (IMDRF-N3) Certificate must reflect the scope of the audit, including regulations covered. Certificate shall not exclude part of processes, products or services from scope of certification X 8.3 Directory of certified clients. X 8.3.1 (IMDRF-N3) AO compliance with RA requirements related to publicly accessible information X 8.4 Reference to certification and use of marks (title only) 8.4.1 AO policy governing any mark it authorizes certified clients to use. X 8.4.2 AO shall not permit its marks to be applied to laboratory test, calibration or inspection reports. X 8.4.3 AO’s requirements of the client medical device manufacturer regarding reference to certification. X 8.4.4 AO ownership of marks and reports and control of use and references. X 8.5 Confidentiality 8.5.1 Policy and arrangements to safeguard confidentiality X 8.5.2 Inform clients in advance of information to be placed in public domain X 8.5.3 Written consent to release information X
imdrf-tech-140918-assessment-decision-process-141013.docx