Tag: SOP for manufacturing medical devices

SOP for Ensuring Compliance with FDA Quality System Regulations (21 CFR 820)

SOP for Ensuring Compliance with FDA Quality System Regulations (21 CFR 820) Comprehensive Guide to Ensuring Compliance with FDA Quality System Regulations (21 CFR 820) 1) Purpose The purpose of this SOP is to define a structured approach for achieving and maintaining compliance with the FDA’s Quality System Regulation (QSR) outlined in 21 CFR Part…

Medical Devices

SOP for Conducting Root Cause Analysis in Quality Control

SOP for Conducting Root Cause Analysis in Quality Control Comprehensive Guide to Conducting Root Cause Analysis in Quality Control 1) Purpose The purpose of this SOP is to establish a systematic procedure for conducting Root Cause Analysis (RCA) in quality control processes. The aim is to identify the underlying causes of non-conformities or issues, implement…

Medical Devices

SOP for Conducting Risk Assessments in Medical Device Design

SOP for Conducting Risk Assessments in Medical Device Design Comprehensive Guide to Conducting Risk Assessments in Medical Device Design 1) Purpose The purpose of this SOP is to establish a systematic approach to conducting risk assessments during the design and development of medical devices. Effective risk assessments ensure compliance with applicable regulations, enhance device safety,…

Medical Devices

SOP for Documenting Hazard Analysis and Critical Control Points (HACCP) in Medical Devices

SOP for Documenting Hazard Analysis and Critical Control Points (HACCP) in Medical Devices Comprehensive Guide to Documenting Hazard Analysis and Critical Control Points (HACCP) in Medical Devices 1) Purpose The purpose of this SOP is to establish a structured approach for documenting Hazard Analysis and Critical Control Points (HACCP) in the development and manufacturing of…

Medical Devices

SOP for Creating Risk Mitigation Plans

SOP for Creating Risk Mitigation Plans Comprehensive Guide to Creating Risk Mitigation Plans for Medical Devices 1) Purpose The purpose of this SOP is to establish a systematic approach for developing risk mitigation plans to address potential hazards associated with medical device design, manufacturing, and post-market activities. These plans ensure compliance with regulatory standards and…

Medical Devices

SOP for Performing Risk-Benefit Analysis of Medical Devices

SOP for Performing Risk-Benefit Analysis of Medical Devices Comprehensive Guide to Performing Risk-Benefit Analysis of Medical Devices 1) Purpose The purpose of this SOP is to define the process for performing a systematic risk-benefit analysis of medical devices. This analysis ensures that the benefits of a device outweigh its risks, supporting regulatory compliance and patient…

Medical Devices

SOP for Managing Risk Control Measures in Manufacturing

SOP for Managing Risk Control Measures in Manufacturing Comprehensive Guide to Managing Risk Control Measures in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a systematic process for identifying, implementing, and managing risk control measures in the manufacturing of medical devices. Effective risk control minimizes potential hazards, ensures compliance with…

Medical Devices

SOP for Post-Market Risk Monitoring of Medical Devices

SOP for Post-Market Risk Monitoring of Medical Devices Comprehensive Guide to Post-Market Risk Monitoring of Medical Devices 1) Purpose The purpose of this SOP is to define a structured process for post-market risk monitoring of medical devices. Post-market monitoring ensures the ongoing evaluation of risks associated with devices in real-world use, supports compliance with regulatory…

Medical Devices

SOP for Documenting Risk Management Activities per ISO 14971

SOP for Documenting Risk Management Activities per ISO 14971 Comprehensive Guide to Documenting Risk Management Activities in Medical Devices 1) Purpose The purpose of this SOP is to establish a systematic process for documenting risk management activities for medical devices in accordance with ISO 14971 standards. Proper documentation ensures compliance with regulatory requirements, facilitates audits,…

Medical Devices

SOP for Conducting Risk Reviews During Product Lifecycle

SOP for Conducting Risk Reviews During Product Lifecycle Comprehensive Guide to Conducting Risk Reviews Throughout the Product Lifecycle of Medical Devices 1) Purpose The purpose of this SOP is to establish a structured approach for conducting risk reviews at various stages of the medical device lifecycle. Regular risk reviews ensure timely identification, evaluation, and mitigation…

Medical Devices