ISO 10993-10:2021 Biological evaluation of medical devices Course Overview

To ensure a successful learning experience in the ISO 10993-10:2021 Biological evaluation of medical devices course, the following prerequisites are recommended:

• Basic understanding of the medical device development and lifecycle processes.
• Familiarity with general biology or biomedical engineering principles.
• Knowledge of quality management systems, particularly as they relate to medical devices (e.g., ISO 13485).
• Awareness of regulatory requirements for medical devices, including those from the FDA, EMA, or other regulatory bodies.
• Prior experience in medical device manufacturing, research, quality assurance, or a related field is beneficial, but not essential for motivated learners.
• Willingness to engage with technical standards and guidelines related to medical device biocompatibility.
• Ability to read and comprehend technical documents and standards in English.

Please note that while having a background in the sciences or medical device field can be advantageous, it is not an absolute requirement. Our course is designed to guide participants through the complexities of ISO 10993-10:2021, building on foundational knowledge to develop expertise. Our instructors are committed to providing support to all learners, regardless of their starting knowledge level.

Target Audience for ISO 10993-10:2021 Biological evaluation of medical devices

Koenig Solutions' ISO 10993-10:2021 course is designed for professionals involved in medical device biological evaluation and regulatory compliance.

• Quality Assurance/Quality Control Specialists
• Regulatory Affairs Managers and Specialists
• Research and Development Engineers
• Biomedical Engineers
• Medical Device Manufacturers and Designers
• Product Safety Engineers
• Clinical Research Associates
• Compliance and Risk Management Officers
• Biocompatibility Consultants
• Laboratory Testing and Validation Technicians
• Toxicologists
• Microbiologists
• Sterilization Specialists
• Packaging Engineers
• Project Managers in Medical Device Development
• Materials Scientists
• Pharmacologists involved in Drug-Device Combination products
• Healthcare Professionals involved in Material Selection for Medical Devices
• Professionals working in Medical Device Software Development and Evaluation
• Post-Market Surveillance Specialists
• Medical Device Auditors and Inspectors

Learning Objectives - What you will Learn in this ISO 10993-10:2021 Biological evaluation of medical devices?

Introduction to the Course's Learning Outcomes:

This comprehensive course on ISO 10993-10:2021 equips participants with the knowledge to conduct biological evaluations of medical devices, ensuring safety and compliance with regulatory standards.

Learning Objectives and Outcomes:

• Understand the principles and requirements of ISO 10993-10:2021, including the biological evaluation process and risk management for medical devices.
• Identify and apply biological endpoints and test methods for assessing medical device biocompatibility.
• Develop strategies for biological evaluation and risk assessment to support regulatory submissions and compliance.
• Interpret biological test results and prepare biological evaluation reports as part of the medical device approval process.
• Assess the biological risks associated with medical device materials, accessories, packaging, and labeling.
• Evaluate the biocompatibility of medical device software, including risk management and post-market surveillance considerations.
• Design and implement quality management systems in line with ISO 10993-10:2021 for medical device biological evaluation.
• Navigate regulatory requirements for medical device combinations, including drug-device and biologic-device combinations.
• Understand the biological evaluation requirements for medical device cleaning, sterilization, and reprocessing.
• Analyze and manage the biological risks throughout the medical device lifecycle, from development to post-market surveillance.