Tag: Medical device post-market surveillance SOP

SOP for Regular Cleaning and Disinfection of Manufacturing Equipment

SOP for Regular Cleaning and Disinfection of Manufacturing Equipment Comprehensive Guide to Regular Cleaning and Disinfection of Manufacturing Equipment for Medical Devices 1) Purpose The purpose of this SOP is to establish a standardized process for cleaning and disinfecting manufacturing equipment used in the production of medical devices. Regular cleaning and disinfection are critical to…

Medical Devices

SOP for Handling and Storing Hazardous Materials in the Facility

SOP for Handling and Storing Hazardous Materials in the Facility Comprehensive Guide to Handling and Storing Hazardous Materials in Medical Device Manufacturing Facilities 1) Purpose The purpose of this SOP is to define the proper procedures for handling and storing hazardous materials in medical device manufacturing facilities. These procedures ensure that hazardous materials are managed…

Medical Devices

SOP for Pest Control in Medical Device Manufacturing Areas

SOP for Pest Control in Medical Device Manufacturing Areas Comprehensive Guide to Pest Control in Medical Device Manufacturing Areas 1) Purpose The purpose of this SOP is to define the process for managing pest control in medical device manufacturing areas. Effective pest control ensures that manufacturing areas remain free of pests, which could compromise product…

Medical Devices

SOP for Equipment Qualification Procedures (IQ, OQ, PQ)

SOP for Equipment Qualification Procedures (IQ, OQ, PQ) Comprehensive Guide to Equipment Qualification Procedures (IQ, OQ, PQ) for Medical Device Manufacturing 1) Purpose The purpose of this SOP is to define the process for qualifying equipment used in medical device manufacturing through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This ensures that…

Medical Devices

SOP for Developing Packaging Specifications for Medical Devices

SOP for Developing Packaging Specifications for Medical Devices Comprehensive Guide to Developing Packaging Specifications for Medical Devices 1) Purpose The purpose of this SOP is to define the process for developing packaging specifications for medical devices. Packaging is critical for ensuring product integrity, safety, and compliance with regulatory standards. This SOP ensures that packaging specifications…

Medical Devices

SOP for Ensuring Labeling Compliance with FDA and EU MDR

SOP for Ensuring Labeling Compliance with FDA and EU MDR Comprehensive Guide to Ensuring Labeling Compliance with FDA and EU MDR 1) Purpose The purpose of this SOP is to establish procedures for ensuring that medical device labels comply with FDA and EU MDR requirements. Accurate and compliant labeling is critical to ensure the safety,…

Medical Devices

SOP for Validation of Packaging Integrity Tests

SOP for Validation of Packaging Integrity Tests Comprehensive Guide to Validation of Packaging Integrity Tests for Medical Devices 1) Purpose The purpose of this SOP is to define the process for validating the packaging integrity tests used in the medical device manufacturing process. Packaging integrity ensures that medical devices remain protected during storage, transportation, and…

Medical Devices

SOP for Managing Batch Numbers and Lot Traceability in Packaging

SOP for Managing Batch Numbers and Lot Traceability in Packaging Comprehensive Guide to Managing Batch Numbers and Lot Traceability in Medical Device Packaging 1) Purpose The purpose of this SOP is to define the process for managing batch numbers and lot traceability in packaging to ensure that medical devices can be traced throughout the manufacturing,…

Medical Devices

SOP for Documenting Packaging Material Approvals

SOP for Documenting Packaging Material Approvals Comprehensive Guide to Documenting Packaging Material Approvals for Medical Devices 1) Purpose The purpose of this SOP is to establish the process for documenting the approval of packaging materials used in the production of medical devices. This ensures that all packaging materials are verified to be suitable, compliant with…

Medical Devices

SOP for Ensuring Compliance with UDI Labeling Requirements

SOP for Ensuring Compliance with UDI Labeling Requirements Comprehensive Guide to Ensuring Compliance with UDI Labeling Requirements for Medical Devices 1) Purpose The purpose of this SOP is to define the process for ensuring compliance with the Unique Device Identification (UDI) labeling requirements for medical devices. The UDI system is crucial for product traceability, post-market…

Medical Devices