Quality Training

Biological Evaluation of Medical Devices, including Chemical Characterization

Full Details

This programme is delivered online over 4 half days from 9am to 13.00pm, details as follows:
- 5th December - Module 1
- 8th December - Module 2
- 13th December - Module 3
- 14th December Module 4

Key learning objectives:
Gain a complete overview of the biocompatibility requirements in the EU and US to ensure compliance
Examine important parts within ISO 10933 to ensure your device manages biological risk
Examine the link between biocompatibility and ISO 14971 risk management
Examine the Medical Device Regulation (MDR) safety requirements in the context of biocompatibility to maintain compliance
How to plan and undertake a biological evaluation of a medical device
Detailed understanding of the chemical characterisation and toxicological evaluation
Explore material characterisation and learn how to characterise novel materials
Benefits of attending:
Build your Biological Evaluation Plan and create a strategy to meet current ISO 10993-1 expectations.
Avoid wasted time in the development process by understanding where your biocompatibility gaps are so that you can address them in a timely manner
Demonstrate to regulatory agencies that the biological evaluation plan was assembled by those with appropriate expertise
”Common pitfalls” – avoid the typical mistakes
Understand biological evaluations to ensure you can outsource effectively and can interpret results
Learn to interpret the requirements to identify and determine testing end-points

Daniele is in the Eurofins group since 2017 dealing with Biological Risk assessments. He is the manager of the Medical Devices Consulting Team in Italy and also manages regulatory consultancy to manufacturers.
He is a Person Responsible for Regulatory Compliance (Senior), a HAS Consultant for the Harmonization of International Standard of Medical devices and he is qualified as Auditor/Lead Auditor ISO 13485/ISO 9001.

Content includes

Module 1: Introduction to the course and overview of biocompatibility
What is biocompatibility and why is a biological evaluation needed?
Examining the ISO 10993 series – biological evaluation
Examine the impact of the Medical device Regulation (MDR)
The relation between ISO 10993 and the risk management standard ISO 14971
Medical device categorization for biological risk assessment
Medical Device Directive (MDD) safety requirements vs the Medical Device Regulation (MDR) safety requirements
MDR, FDA and biocompatibility
Evaluation and testing within a risk management process: Use of ISO 10993-1
Chemical Characterization and Toxicological Evaluation: Use of ISO 10993-18 & -17
Module 2: Biological evaluation – FAB four
Biocompatibility testing – Endpoints to be addressed in a biological risk assessment
GLP requirements
Lab selection
FAB FOUR: Cytotoxicity, irritation, sensitisation and acute systemic toxicity
Endotoxin contamination and material mediated pyrogenicity: US-FDA expectations
What you should consider in the communication with the test-house
Module 3: Long term toxicity and sample preparation
Genotoxicity ISO 10993-3 “Tests for genotoxicity, carcinogenicity and reproductive toxicity” & ISO/TR 10993-33 “Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3”
ISO 10993-4: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood
Sample Preparation ISO 10993-12 “Biological evaluation of medical devices -Part 12: Sample preparation and reference materials”
Module Module 4: Chemical Characterization and Toxicological Evaluation: Use of ISO 10993-18 & -17
Physical and Chemical characterisation as part of material qualification and selection
Summary of the different steps to be addressed for a proper Extractables-Leachables Screening Study
Illustration of different study designs which may be applied for complex materials consisting of many different parts
Overview and selection of chemical testing methods for material characterization and the use of results
Definition of an appropriate Tolerable Exposure (TE)
Selection of different approaches to address a toxicological assessment
Pills on the new version of ISO 10993-17 (ISO/FDIS: Final Draft of International Standard)
Conclusions and next step after a Toxicological Risk Assessment

Who should attend

Medical Technology Professionals


Certificate of Attendance

Upcoming dates:

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Biological Evaluation of Medical Devices, including Chemical Characterization

Training Days

4 Sessions

Training Location

Available nationally, based on demand

Course Cost

Member: €375
Non-member: €500
* Cost quoted per person

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