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

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

The ISO 10993-10:2021 Biological evaluation of medical devices course provides comprehensive training on the principles and practices outlined in the ISO 10993-10 standard, which focuses on tests for irritation and skin sensitization. Learners will gain an in-depth understanding of biological evaluation principles, various biological endpoints, and the selection of appropriate test methods. The course covers the process of biological risk assessment, management, and the creation of biological evaluation reports.

Participants will learn how to develop strategies for the biological evaluation of medical devices, including combination products, biomaterials, and drug-device combinations. Regulatory requirements for the biological evaluation of medical devices are also addressed, ensuring that learners understand the necessary steps to comply with international regulations.

By completing this course, learners will be equipped to conduct thorough biological evaluations, manage risks effectively, and ensure the safety and efficacy of medical devices throughout their lifecycle. This knowledge is crucial for professionals involved in the design, testing, and regulatory approval of medical devices.

This is a Rare Course and it can be take up to 3 weeks to arrange the training.

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♱ Excluding VAT/GST

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Course Prerequisites

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.