Tag: SOP for risk management in medical devices

SOP for Ensuring Compliance with Sterile Packaging Standards

SOP for Ensuring Compliance with Sterile Packaging Standards Comprehensive Guide to Ensuring Compliance with Sterile Packaging Standards for Medical Devices 1) Purpose The purpose of this SOP is to define the process for ensuring compliance with sterile packaging standards for medical devices. Sterile packaging is essential for maintaining the sterility of medical devices until they…

Medical Devices

SOP for Documenting Packaging Defect Reports

SOP for Documenting Packaging Defect Reports Comprehensive Guide to Documenting Packaging Defect Reports for Medical Devices 1) Purpose The purpose of this SOP is to establish the process for documenting packaging defect reports for medical devices. Packaging defects can impact the sterility, safety, and integrity of medical devices. This SOP ensures that packaging defects are…

Medical Devices

SOP for Managing Design History Files (DHF)

SOP for Managing Design History Files (DHF) Comprehensive Guide to Managing Design History Files (DHF) in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to define a structured approach for creating, maintaining, and managing Design History Files (DHF) for medical devices. The DHF ensures that all design and development activities comply with…

Medical Devices

SOP for Ensuring Compliance with ISO 13485 Standards

SOP for Ensuring Compliance with ISO 13485 Standards Comprehensive Guide to Ensuring Compliance with ISO 13485 Standards in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to define the procedures necessary to achieve and maintain compliance with ISO 13485 standards. ISO 13485 specifies requirements for a quality management system (QMS) in medical…

Medical Devices

SOP for Validation of Measurement Systems

SOP for Validation of Measurement Systems Comprehensive Guide to Validation of Measurement Systems in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a systematic procedure for validating measurement systems used in medical device manufacturing. Proper validation ensures the accuracy, precision, and reliability of measurement systems, thereby maintaining product quality and…

Medical Devices

SOP for Risk Management Documentation in Medical Devices (ISO 14971)

SOP for Risk Management Documentation in Medical Devices (ISO 14971) Comprehensive Guide to Risk Management Documentation in Medical Devices (ISO 14971) 1) Purpose The purpose of this SOP is to establish a standardized procedure for documenting risk management activities for medical devices in compliance with ISO 14971. Proper documentation ensures systematic identification, assessment, control, and…

Medical Devices

SOP for Conducting Internal Quality Audits

SOP for Conducting Internal Quality Audits Comprehensive Guide to Conducting Internal Quality Audits 1) Purpose The purpose of this SOP is to establish a systematic approach to planning, conducting, and documenting internal quality audits. These audits ensure that processes comply with established quality management system standards, regulatory requirements, and organizational policies, and that opportunities for…

Medical Devices

SOP for Documentation of CAPA in Quality Assurance

SOP for Documentation of CAPA in Quality Assurance Comprehensive Guide to Documentation of CAPA in Quality Assurance 1) Purpose The purpose of this SOP is to establish a standardized process for documenting Corrective and Preventive Actions (CAPA) in quality assurance. Proper documentation ensures traceability, regulatory compliance, and continuous improvement in manufacturing processes and quality systems….

Medical Devices

SOP for Handling Deviations in Manufacturing Processes

SOP for Handling Deviations in Manufacturing Processes Comprehensive Guide to Handling Deviations in Manufacturing Processes 1) Purpose The purpose of this SOP is to define a structured approach for identifying, documenting, evaluating, and resolving deviations in manufacturing processes. The goal is to ensure compliance with regulatory requirements, maintain product quality, and prevent recurrence of deviations….

Medical Devices

SOP for Calibration of Quality Testing Equipment

SOP for Calibration of Quality Testing Equipment Comprehensive Guide to Calibration of Quality Testing Equipment in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a systematic procedure for calibrating quality testing equipment used in medical device manufacturing. Proper calibration ensures accurate, reliable measurements, compliance with regulatory standards, and the production…

Medical Devices