Tag: FDA Medical device SOP requirements

SOP for Evaluating Supplier Risk in the Supply Chain

SOP for Evaluating Supplier Risk in the Supply Chain Comprehensive Guide to Evaluating Supplier Risk in the Supply Chain for Medical Devices 1) Purpose The purpose of this SOP is to establish a structured approach for evaluating supplier risks in the supply chain of medical devices. The evaluation ensures the selection of reliable suppliers, minimizes…

Medical Devices

SOP for Monitoring Emerging Risks in Medical Device Technology

SOP for Monitoring Emerging Risks in Medical Device Technology Comprehensive Guide to Monitoring Emerging Risks in Medical Device Technology 1) Purpose The purpose of this SOP is to define a systematic approach for identifying, evaluating, and monitoring emerging risks associated with medical device technology. Proactive risk monitoring ensures the early detection of potential hazards, compliance…

Medical Devices

SOP for User Needs and Requirement Specification

SOP for User Needs and Requirement Specification Comprehensive Guide to Developing User Needs and Requirement Specifications for Medical Devices 1) Purpose The purpose of this SOP is to define the process for identifying, documenting, and managing user needs and requirement specifications for medical devices. This ensures that devices are designed to meet user expectations, functional…

Medical Devices

SOP for Creating Functional Specifications for Medical Devices

SOP for Creating Functional Specifications for Medical Devices Comprehensive Guide to Creating Functional Specifications for Medical Devices 1) Purpose The purpose of this SOP is to establish a systematic process for creating and managing functional specifications for medical devices. Functional specifications define the operational requirements and ensure that the device meets user needs, regulatory requirements,…

Medical Devices

SOP for Conducting Design Reviews

SOP for Conducting Design Reviews Comprehensive Guide to Conducting Design Reviews for Medical Devices 1) Purpose The purpose of this SOP is to define a structured process for conducting design reviews during the development of medical devices. Design reviews ensure that the device meets user needs, safety standards, and regulatory requirements while identifying and addressing…

Medical Devices

SOP for Developing Prototypes of Medical Devices

SOP for Developing Prototypes of Medical Devices Comprehensive Guide to Developing Prototypes of Medical Devices 1) Purpose The purpose of this SOP is to outline the process for developing, testing, and evaluating prototypes of medical devices. Prototyping ensures that design concepts meet functional, safety, and usability requirements before moving to production. 2) Scope This SOP…

Medical Devices

SOP for Documenting Design Inputs and Outputs

SOP for Documenting Design Inputs and Outputs Comprehensive Guide to Documenting Design Inputs and Outputs for Medical Devices 1) Purpose The purpose of this SOP is to establish a standardized process for documenting design inputs and outputs during the medical device development lifecycle. Proper documentation ensures alignment with user needs, regulatory compliance, and product safety…

Medical Devices

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