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Dublin, January 18, 2024 (GLOBE NEWSWIRE) — The “Medical Device Biological Evaluation Training Course” has been added to the ResearchAndMarkets. com offering.
The ISO 10993 series of criteria covering the biological evaluation of medical devices has been established and regulatory governments around the world are waiting for compliance.
In Europe, compliance with the standards is the easiest way to meet the essential product safety requirements of the MDR and understanding a risk management approach to biological safety is essential.
This seminar will provide key guidance on how to use criteria and effectively apply a threat control technique to the biological evaluation of medical devices. There will be plenty of time during the program for interactive discussions with experts in this field.
Benefits of participating:
Understand biological risk management
Clarify the requirements of ISO 10993-1
Find out what parameters should be taken into account in a biological threat assessment
Establish how much chemical characterisation is necessary
Listen to the FDA’s statements on ISO 10993
Better perceive the protection needs of the Medical Devices Directive (MDD) than the protection needs of the Medical Devices Regulation (MDR)
Know how extractables and leachables impact on medical device safety
Analyze Japanese and Chinese requirements.
Certifications:
CPD: 12 hours for your files
Certificate of Completion
The occasion will be of importance to medical device industry players from the following departments:
Regulatory affairs
R
Product safety/toxicology
Analytical chemistry
Risk assessment and management
Research and evaluation of materials.
It will also be of interest to regulatory authorities, Notified Bodies and CROs supporting the medical device industry.
Course syllabus:
Day 1
An Introduction to Biological Assessment
Overview of Biocompatibility
ISO 10993 History and development/ISO 10993 Structure and content
Relationship Between Regulatory Standards
Impact of the MDR
Impact of Brexit
Gap Analysis of Existing Biocompatibility Data
Medical Device Categorisation for Biological Risk Assessment + Practical Exercise
Parameters That Should Be in a Biological Threat Assessment
GLP Requirements
Laboratory Selection
Day 2
Physical and chemical characterization.
Extractables and Leachables Testing: When and Why?Practical Exercise
Using QSAR
Use of Data Sources to and Literature Searching
Change Management
International Requirements
Practical Exercise of Gas Tracking Devices
Speakers: Philip Clay, Director, Senior Toxicologist. Chorley Consulting
Philip Clay is a principal and senior toxicologist at Chorley Consulting. He is a registered toxicologist in the UK and Europe and specialises in product protection assessment with over 30 years’ experience in toxicology and protection assessment. He is a member of the BSI Committee on CH/194. (Biological Evaluation of Medical Devices) and Senior Expert in WG6 (Mutagenicity, Carcinogenicity and Reproductive Toxicity).
Philip has established his reputation as a genetic toxicologist in the agrochemical, chemical and pharmaceutical industries. He has contributed to expert panels, helping to shape the rules and testing methods in place today. More recently, this experience and in-depth knowledge has been implemented. to the design of protection assessment systems for medical devices and healthcare products for a wide variety of customers. Philip is currently a member of a specialized panel of the Consumer Healthcare Products Association (CHPA) that is lobbying the U. S. FDA to repeal. In the U. S. in relation to the use of in vitro. Knowledge in the evaluation of biocompatibility of medical devices.
He has extensive experience in assessing the biosafety of a wide variety of medical devices, from Class 1 customer fitness devices to Class 3 implantable devices. He is an expert speaker at clinical meetings and has provided biosecurity assessment trainings around the world.
Rona Middlemiss, Chorley Consulting
Rona is a Senior Safety Advisor at Chorley Consulting. She holds a top-notch Master’s degree in Biomedical Sciences from the University of Aberdeen. In addition, he completed educational courses on the practical application of toxicology in drug progression, as well as the Personal Animal Licensing Course, Modules 1-3. He spent his year in the industry with a multinational manufacturer of medical products and devices for customer healthcare, reveling in evaluating medical device protection. He joins Chorley from a clinical position at British American Tobacco, where he honed his skills in toxicology by assessing toxicological threats for harm relief products. Rona brings to Chorley the experience of a healthcare medical device manufacturer, as well as the toxicological threat assessment skills gained during her tenure at BAT.
During her time with Chorley, Rona has rapidly developed her skills in performing toxicological risk assessments of extractable and leachable data including the use of in silico tools for the prediction of toxicological effects. She has also developed her presentation skills, having presented a number of on-line training modules around various aspects of Biological Evaluation of Medical Devices.
For more information about this conference, https://www. researchandmarkets. com/r/jai15q
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