Biological Evaluation in Medical Devices (EN ISO 10993-1:2020) Training

The EN ISO 10993-1:2020 standard is a standard used in the medical device industry to ensure that products that come into direct or indirect contact with the human body meet biocompatibility requirements before being placed on the market. The purpose of this standard is to identify the potential risks of materials and products used to humans and to provide a framework for managing these risks. It explains how biological tests should be planned and implemented to evaluate the materials and components used in medical devices and determine their potential effects on human health. The scope of this training includes the planning, execution and documentation of biological assessment.

Purpose of Training:

EN ISO 10993-1:2020 Biological Assessment Training in Medical Devices helps professionals operate successfully in the medical device industry by providing them with knowledge on important issues such as product safety and compatibility, regulatory compliance, planning and execution of tests, material selection and risk assessment.

Content of the Training:

• Biocompatibility requirements under MDR
• Definitions related to biological evaluation
• General principles
• Biological classification of medical devices
• Evaluation of physical and chemical information
• biological tests
• Risk analysis and biological assessment
• Biological evaluation report
• Situations in which biological risk assessment will be re-evaluated

Who Should Participate:

• Licensing Experts
• Medical Device R&D Engineers
• Medical Device Manufacturers
• Internal and External Auditors
• Quality Managers
• Development, Production and Marketing Managers
• Clinical Experts
• Authorized representatives
• People who want to improve themselves in biological evaluation
• Consultants

Benefits of Education:

To better understand the effects of medical devices on human health and to determine the necessary methods to minimize these effects.

Ability to gain competitive advantage in the market by ensuring the biological compatibility and safety of products

By planning and testing the biological compatibility of products from the beginning, it is possible to prevent corrections and recalls that may arise in the product in the future.

Ability to evaluate and manage biological risks

Ability to determine the necessary biocompatibility tests for the product, justify unnecessary tests, and justify the worst-case scenario

Reference Sources:

(EU) 2017/745 Medical Device Regulation

EN ISO 10993-1: 2020

Tuition Fee:

Please send an e-mail to info@udem.com.tr to get information about training fees. If there are 3 or more participants from the same company/institution, a 10% discount will be given. A 10% discount will be provided for participants who register early.

Education Record:

To complete the training registration, please fill out the training registration form in the link below and send an e-mail to info@udem.com.tr.

Detailed Information:

For detailed information about the training, you can contact us through the following communication channels.

Tel: +90 312 4430390

Mail: info@udem.com.tr