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General Material Properties of Absorbable Products - Quality Control and Performance Tests, Technical Documentation Requirements - Issues to be Considered in Conformity Assessments
Sterile Packaging Materials-General Requirements-Relevant Standards
Stability (Accelerated and Real Time) Studies in Medical Devices - General Principles-Reporting Rules
Production Methods of Wound Care Products, Process Validations, Quality Control Tests and Issues to be Considered in Conformity Assessments
Nanomaterials in Medical Device Usage
Machinery Directive 2006/42/EC Training
Chemical Characterization Tests
Packaging and Transport Validation and Routine Controls (EN ISO 11607)
Requirements for aseptic processing of medical devices , EN 556-2, EN ISO 13408 series based on conformity assessment approach
Requirements for the development, validation and routine control of ethylene oxide sterilization process for medical devices (EN ISO 11138, EN ISO 14937, EN ISO 10993-7)
Requirements for the development, validation and routine control of low temperature vaporized hydrogen peroxide sterilization process for medical devices
Requirements for the development, validation and routine control of a radiation sterilization process for medical devices (EN ISO 11137-1, 2, 3)”
Requirements for the development, validation and routine control of moist heat sterilization process for medical devices (EN ISO 17665)
Medical Device Sterilization- Microbiological Methods (EN ISO 11737-1, EN ISO 11737-2)”
Clean Room Technologies and Clean Room Validation (EN ISO 14644 Series)
EN 62366-1 Usability in Medical Devices-General Rules-Reporting
EN ISO IEC 60601-1
Biological Evaluation of Medical Devices (EN ISO 10993 Series)
Hygiene, Disinfection, Sanititation
(EU) 217/745 Annex XV Clinical Investigations
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