Tag: FDA Medical device SOP requirements

SOP for Verification and Validation Testing of Device Design

SOP for Verification and Validation Testing of Device Design Comprehensive Guide to Verification and Validation Testing of Device Design 1) Purpose The purpose of this SOP is to establish a structured process for conducting verification and validation (V&V) testing of medical device designs. This ensures that devices meet design specifications and intended user needs while…

Medical Devices

SOP for Managing Design Changes and Documentation

SOP for Managing Design Changes and Documentation Comprehensive Guide to Managing Design Changes and Documentation for Medical Devices 1) Purpose The purpose of this SOP is to define a structured process for managing design changes and associated documentation for medical devices. Proper management ensures that design modifications are systematically evaluated, implemented, and documented to maintain…

Medical Devices

SOP for Human Factors Engineering and Usability Testing

SOP for Human Factors Engineering and Usability Testing Comprehensive Guide to Human Factors Engineering and Usability Testing for Medical Devices 1) Purpose The purpose of this SOP is to define the process for integrating human factors engineering (HFE) and conducting usability testing in the development of medical devices. These practices ensure that devices are safe,…

Medical Devices

SOP for Creating Engineering Drawings and Specifications

SOP for Creating Engineering Drawings and Specifications Comprehensive Guide to Creating Engineering Drawings and Specifications for Medical Devices 1) Purpose The purpose of this SOP is to establish a standardized process for creating and managing engineering drawings and specifications for medical devices. These documents ensure that design details are accurately communicated for manufacturing, validation, and…

Medical Devices

SOP for Documenting Software Development in Medical Devices

SOP for Documenting Software Development in Medical Devices Comprehensive Guide to Documenting Software Development in Medical Devices 1) Purpose The purpose of this SOP is to establish a standardized process for documenting software development activities related to medical devices. Proper documentation ensures compliance with regulatory requirements, traceability, and alignment with user needs and safety standards….

Medical Devices

SOP for Validation of Manufacturing Equipment

SOP for Validation of Manufacturing Equipment Comprehensive Guide to Validation of Manufacturing Equipment for Medical Devices 1) Purpose The purpose of this SOP is to define the process for validating manufacturing equipment used in the production of medical devices. Equipment validation ensures that devices are consistently manufactured according to design specifications, regulatory requirements, and quality…

Medical Devices

SOP for Cleanroom Maintenance and Monitoring

SOP for Cleanroom Maintenance and Monitoring Comprehensive Guide to Cleanroom Maintenance and Monitoring for Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized process for maintaining and monitoring cleanrooms used in the manufacturing of medical devices. Proper cleanroom management ensures that the environment is controlled to prevent contamination and…

Medical Devices

SOP for Environmental Monitoring in Manufacturing Areas

SOP for Environmental Monitoring in Manufacturing Areas Comprehensive Guide to Environmental Monitoring in Manufacturing Areas for Medical Device Production 1) Purpose The purpose of this SOP is to define the process for monitoring environmental conditions in manufacturing areas used for the production of medical devices. Proper monitoring ensures that environmental factors such as temperature, humidity,…

Medical Devices

SOP for Calibration and Maintenance of Sterilization Equipment

SOP for Calibration and Maintenance of Sterilization Equipment Comprehensive Guide to Calibration and Maintenance of Sterilization Equipment for Medical Device Manufacturing 1) Purpose The purpose of this SOP is to define the process for calibrating and maintaining sterilization equipment used in the production of medical devices. Proper calibration and maintenance ensure that sterilization equipment performs…

Medical Devices

SOP for Ensuring Utility Validation in Manufacturing Facilities

SOP for Ensuring Utility Validation in Manufacturing Facilities Comprehensive Guide to Ensuring Utility Validation in Manufacturing Facilities for Medical Devices 1) Purpose The purpose of this SOP is to define the process for validating utilities used in manufacturing facilities, ensuring that these systems operate within specified parameters to support the production of safe and effective…

Medical Devices