Medical Device Training Programs
Quality Management System (QMS)
ISO 13485:2016 specifies requirements for a Quality Management System (QMS) tailored for the medical device industry. It focuses on consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. The standard ensures compliance with regulatory requirements and enhances product quality and safety.
Introduction to Implementation of the Laboratory Quality Management System
ISO 17025 implementation focuses on establishing a Laboratory Quality Management System to ensure consistent, reliable testing and calibration results. It involves defining procedures, training staff, maintaining equipment, and conducting regular audits to comply with international standards, thus enhancing laboratory credibility and fostering customer trust in its services.
Application of Risk Management to Medical Devices
ISO 14971:2019 outlines a framework for applying risk management to medical devices. It emphasizes identifying, evaluating, and controlling risks throughout a device's lifecycle, ensuring patient safety. The standard guides manufacturers in making informed decisions, balancing benefits and risks, and complying with regulatory requirements to enhance healthcare outcomes.
Gamma Irradiation Sterilization
ISO 11137:2017 sets guidelines for gamma irradiation sterilization of healthcare products. It encompasses the validation, process control, and documentation necessary to ensure product safety and effectiveness. This standard helps in achieving sterility assurance, minimizing contamination risks, and maintaining product integrity, crucial for patient safety and regulatory compliance in the healthcare sector.
Ethylene Oxide Gas Sterilization
ISO 11135:2014 provides comprehensive guidelines for ethylene oxide gas sterilization in the healthcare industry. It covers the requirements for development, validation, and routine control of a sterilization process for medical devices. This standard ensures effective sterilization while maintaining device integrity, essential for patient safety and regulatory compliance.
Moist Heat Sterilization
ISO 17665:2006 details the requirements for moist heat sterilization processes in healthcare. It covers the validation, control, and monitoring of sterilization methods using saturated steam or water, ensuring the safe and effective sterilization of medical devices. This standard is crucial for maintaining product safety and compliance in the medical industry.
Packaging for Terminally Sterilized Medical Devices
ISO 11607 outlines requirements and test methods for packaging terminally sterilized medical devices. It ensures packaging is suitable for sterilization, provides physical protection, maintains sterility up to the point of use, and is materials-safe. This standard is vital for device safety, effectiveness, and regulatory compliance.
Training Related to Medical Devices
ISO 11737-1 Bioburden Test
ISO 11737-1 specifies the procedures for determining microbial contamination (bioburden) on medical devices before sterilization. It guides on sampling, microbiological methods, and quantification, helping to assess and control bioburden levels. This testing is vital for validating sterilization processes, ensuring product safety, and complying with healthcare regulations. We offer three level of training program. Choose a program level based on your knowledge: Beginner for fundamentals, Intermediate to build on basic understanding, or Expert for advanced concepts and practices. Select according to your current skills and learning goals.