Biocompatibility of Medical Devices
Understand the requirements for demonstrating the biocompatibility of medical devices.
3 half-days of training | Virtual Classroom
About the training
GMED North America has designed a comprehensive training course to help understand the requirements for demonstrating biocompatibility of medical devices through the following objectives:
- Identify parameters that have an impact on biocompatibility in order to better control them.
- Understand the requirements for demonstrating the biocompatibility of medical devices.
- Establish and understand the preclinical testing plan for product and patient safety.
REQUIRED LEVEL
- General knowledge of issues relating to the biocompatibility of healthcare products
Sharifi Shahriar Medical Device Specialist
Dr. Shahriar Sharifi is a medical device expert with a Ph.D. in Biomedical Engineering from the University of Groningen, The Netherlands. His expertise includes designing and optimizing biomaterials and nanomaterials, as well as assessing their biocompatibility for applications in implants and wound healing.
With over 70 scientific publications, his expertise encompasses nanomaterial toxicity, hydrogels, and resorbable medical devices. Dr. Sharifi has held several roles in academia and industry, including Principal Scientist and Medical Device Expert. Currently, he serves as a Product Reviewer and Biocompatibility Subject Matter Expert at G-Med North America, overseeing medical device development and regulatory compliance.
Who Should Attend
- Medical device manufacturers: Senior Management, Regulatory Affairs Managers and Quality Managers, R&D Specialists, Development, Manufacturing and Marketing Managers
- Raw Material Suppliers
- Material Safety Officers
Learning Objectives
- Identify parameters that have an impact on biocompatibility in order to better control them
- Understand the requirements for demonstrating the biocompatibility of medical devices
- Establish and understand the preclinical testing plan for product and patient safety
Educational Resources
- Presentations
- Practical working sessions
- Course evaluation
Check out the Program
- Relationship between EN ISO 10993-1 and the requirements of EU regulation 2017/745 Link to other standards essential to the application of ISO 10993-1 General principles of ISO 10993-1
- Input data for the application of ISO 10993-1 Approach and methodology according to ISO 10993-1
- Elements to consider for relevance in device evaluation Definition of materials to finished product for preclinical evaluation Classification of medical devices
- Biological evaluation process
- Biological evaluation trials/pre-clinical tests
- Analytical methods and techniques – biological techniques Analytical methods and techniques – chemical techniques
- Biological assessment of medical devices as part of a risk management process Biocompatibility of materials/biocompatibility of processes
- Post-production information, feedback, material vigilance Review of scientific literature: methodology
- Review of scientific literature: recommendations Review of scientific literature: preparation of report
- Case study based on the ISO 10993-17 and ISO 10993-18 approaches Course evaluation, summary and conclusions
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