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EN ISO 13485 Quality Management System

TS EN ISO / IEC 17025 General requirements for the competence of testing and calibration laboratories

TS EN ISO / IEC 17025 General requirements for the competence of testing and calibration laboratories
Requirements for the development, validation and routine control of moist heat sterilization process for medical devices (EN ISO 17665) with conformity assessment approach
EN ISO 13485/ISO 9001 Quality Management System Lead Auditor/Auditor Training
Production Methods of Disinfectant Products, Process Validations, Quality Control Tests and Issues to be Considered in conformity assessments
Dialyser Production - Quality Control tests - Process validation - Requirements to be considered in conformity assessments
Hemodialysis Solution Production - Quality Control tests - Process validation - Requirements to be considered in conformity assessments
Medical Devices Incorporating Medicinal Substances - Quality Control and Performance Tests and Process Validation - Issues to be Considered in Conformity Assessments
Production Technologies of Cardiovascular Products, Quality Control and Performance Tests of and Process Validation-Issues to be Considered in Conformity Assessments
General Rules of Heat Treatment and Production Technologies, Quality Control and Performance Tests - Issues to be Considered in Conformity Assessments
Powder Metallurgy Manufacturing Methods and Issues to be Considered - Quality Control Tests - Issues to be Considered in Conformity Assessments
Machining and Casting Manufacturing Methods - Quality Control and Performance Tests - Issues to be Considered in Conformity assessments
General Rules for the Production Technologies of Orthopedics and Trauma Implants, Quality Control and Performance Tests - Issues to be Considered in Conformity Assessments
Use of Polymers in Non-Implanted, Single Use Medical Devices - General Features - Quality Control and Performance Tests - Issues to be Considered in Inspections
Issues to be Considered in Injection Production Process-Rules Regarding Process Validation
Coating and Surface Treatment Technologies in Medical Devices
Dental Implant Production Technologies - General Rules - Quality Control and Performance Tests - Issues to be Considered in Conformity Assessments
Rules and Requirements for Installation and Operation in Establishments with Ethylene Oxide Sterilizers
Soft Tissue Implants - General Material Properties - Quality Control and Performance Tests - Issues to be Considered in Conformity Assessments
General Rules of Cement and Greft Production Technologies, Quality Control and Performance Tests - Issues to be Considered in Conformity
General Rules of Ceramic and Polymer-Based Production Technologies, Quality Control and Performance Tests-Issues to be Considered in Conformity Assessments
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