Sampling method. Assessment of the efficiency of any quality assurance system and documentation by means of reviewing implementation samples. This method is not based on reviewing all the documentation and files. The frequency of sampling may change. PSUR: Periodic safety update report SSCP: Summary of safety and clinical performance EUDAMED: Electronic System implemented by EU Commission.
Appears in 2 contracts
Sources: Product Conformity Assessment Agreement, Product Conformity Assessment Agreement
Sampling method. Assessment of the efficiency of any quality assurance system and documentation by means of reviewing implementation samples. This method is not based on reviewing all the documentation and files. The frequency of sampling may change. MDR: Regulation (EU) 2017/745 - Medical Device Regulation PSUR: Periodic safety update report SSCP: Summary of safety and clinical performance EUDAMED: Electronic System implemented by EU Commission.report
Appears in 1 contract
Sources: Agreement