Biological Safety Evaluation of Medical Devices based on ISO 10993
- Understand the principles governing the biological evaluation of medical devices based on risk management process.
- Medical devices categorization based on
- Nature of contact
- Duration of contact
- Implement the strategy and stepwise approach to identify the biological end points
- Biological risk/safety assessment based on toxicological end points
- Biocompatibility test methods based on ISO 10993 standards
- ISO 10993-Part 3
- ISO 10993-Part 4
- ISO 10093-Part 5
- ISO 10993-Part 6
- ISO 10993-Part 10
- ISO 10993-Part 11
- Recent changes in the standards to fulfill regulatory requirements.
3D Printing of Medical Devices - Technical Requirements to Satisfy Regulation
- Understanding fundamentals of 3D printing
- Lear about 3D Printing Processes that can be used for medical device manufacturing
- Advantages and challenges in using 3D Printing for medical Devices
- Understanding the regulatory landscape for 3D Printed medical devices
- Understand the workflow in producing a medical device using 3D printing.
- Understand the impact on material depended variability
- Understand the impact on process depended variability
- Testing requirements for 3D printed devices
- Understand the impact on secondary processes/post processing
- Understanding the issues in cleaning and sterilization of 3D printed devices
Date: August 21st 2018
Location: Biopolis @ One-north, Aspiration Theatre, Matrix Building (Level 2M), Singapore
Haribabu Sudarsanam, Engineer at UL India.
Haribabu is a toxicologist and subject matter expert in biological safety evaluation of medical devices at UL India since May 2017. He has completed Master’s in biotechnology and he is a FELASA certified laboratory animal scientist. He has been a member of Laboratory Animal Scientist Association, India for the past 3 years.
He has knowledge in ISO 10993 standards and requirements and 10 years of experience in biological safety evaluation of different classes of medical devices, toxicology evaluation of pharmaceuticals, cosmetics, drugs, chemicals etc. His area of expertise include toxicology risk assessment of medical devices, packaging validation of medical devices, USP requirements for medical device raw materials and material selection for Medical device packaging. He has undergone Train The Trainer (TTT) training program and gave many international and national seminars about ISO 10993. He recently delivered ISO 10993 training to Saudi FDA.
Dr. Khalid Rafi, Lead Engineer for UL-Additive Manufacturing.
He has over 17 years of Training and Research experience and serves as a participating member in various international standard development committees such as ISO/ASTMF42, America Makes Standards Consortium (AMSC), and ASME. He has authored over 40 research papers in reputed international journals and conference proceedings.
In UL, his focus is on developing procedures, guidelines and best practices for Additive Manufacturing Materials and Processes. He is also a Master Trainer for Additive Manufacturing courses offered by UL and content developer for the courses. He works very closely with Additive Manufacturing Industry as a consultant and as a collaborator in various projects.
Dr. Rafi has received a Masters and Ph.D in Metallurgy and Material science, from Indian Institute of Technology Madras and Research Fellowships from University of Louisville, USA and NTU Singapore.
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