Iso 13485 summary11/19/2022 ![]() ![]() 8.2.2 Complaint handling (SOP + record).8.2.1 Customer feedback system/process (SOP).7.6 Monitoring and measuring equipment (SOP + records).7.5.11 Preservation of product (SOP + record).7.5.9.2 Particular requirements for implantable medical devices (record).7.5.8 Returned Device Identification (SOP).7.5.7 Validation of processes for sterile barrier systems (SOP + record).7.5.7 Validation of processes for sterilization (SOP + record).7.5.6 Production/service provision software validation (SOP + record).7.5.6 Production/service provision process validation (SOP + record).7.5.5 Particular requirements for sterile medical devices (record).7.5.4 Servicing activities (SOP + record).7.5.3 Requirements for medical device installation and acceptance criteria for verification of installation (document + record).7.5.2 Requirements for cleanliness of product (document).7.5.1 Production control (SOP + record).7.4.3 Verification of purchased product (record).7.4.1 Purchasing process (SOP + record).7.3.9 Design and development changes (SOP + record).7.3.8 Design and development transfer (SOP + record).7.3.4 Design and development validation.7.3.1 Design and development (SOP + record).7.2.3 Arrangements for communicating with customers (document).7.2 Customer related process (document + record).7.1 Process for Risk Management (document + record).6.4.2 Arrangements for the control of contaminated or potentially contaminated product.6.4.1 Requirements for health, cleanliness and clothing of personnel (document).6.4.1 Work Environment monitoring and control (SOP).6.4.1 Requirements for work environment (document).6.3 Requirements for maintenance (document).6.3 Requirements for Infrastructure (document + record).6.2 Personnel competence/training (SOP + record).5.5.1 Responsibility and authority (document).4.1.6 QMS software computer validation (SOP +records).4.1.5 Quality Agreements with outsource supplier (document).4.1 General requirements & 4.2.1 other documentation specified by applicable regulatory requirements.(document).Easy Guide on how to comply to MDR and ISO 13485 contents.How to use “Easy Guide on how to comply to MDR and ISO 13485”.Introduction: Easy Guide on how to comply to MDR and ISO 13485. ![]()
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