Presented by
Management Forum
Biological Evaluation of Medical Devices In-house Training
Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices. *Includes:* Interactive workshops and discussion sessions
★★★★★ "The course was very insightful and gave me a better understanding of the process and required effort... more (12)"
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
Course overview
Ensure compliance with the ISO 10993 series of standards for the biological evaluation of medical devices, as it is well-established and expected by regulatory authorities worldwide.
In the European Union, compliance with these standards is crucial for meeting the essential safety requirements outlined in the Medical Device Regulation (MDR). Understanding and implementing a comprehensive risk management strategy for biological safety is therefore paramount.
This seminar offers essential guidance on effectively utilizing the ISO 10993 standards and integrating a robust risk management approach into the biological evaluation process of medical devices. Participants will have ample opportunity to engage in interactive discussions with industry experts, gaining practical insights and best practices.
Attendees will emerge equipped with the knowledge and tools necessary to navigate regulatory requirements, mitigate risks, and ensure the safety and efficacy of medical devices in compliance with global standards.
This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.
Benefits of attending
- Understand biological risk management
- Clarify the requirements of ISO 10993-1
- Learn what endpoints need to be addressed in a biological risk assessment
- Establish how much chemical characterisation is necessary
- Explore the FDA’s approach to ISO 10993
- Comprehend the Medical Device Directive (MDD) safety requirements vs the Medical Device Regulation (MDR) safety requirements
- Recognize how extractables and leachables impact medical device safety
- Discuss the Japanese and Chinese requirements
Who should attend?
The event will be of particular importance to those in the medical device industry from the following departments:
- Regulatory affairs
- R&D
- Product safety/toxicology
- Analytical chemistry
- Risk assessment and risk management
- Materials research and evaluation
It will also be of interest to regulatory authorities, Notified Bodies and CROs supporting the medical device industry.
This course will cover:
Introduction to biological evaluation
Overview of biocompatibility
ISO 10993 history and development / ISO 10993 structure and content
Relationship between regulatory standards
Impact of MDR
Impact of Brexit
Gap analysis of existing biocompatibility data
Medical device categorisation for biological risk assessment
Endpoints to be addressed in a biological risk assessment
GLP requirements
Lab selection
Physical and chemical characterisation
Extractables and leachables testing - when and why?
Use of QSAR
Use of data sources to and literature searching
Change management
International requirements
Gas pathway devices
- Practical exercise
Annette Callaghan
Sterile Management Systems
A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).
Reviews of IPI's Biological Evaluation of Medical Devices training course
The course was very insightful and gave me a better understanding of the process and required effort. Excellent and knowledgeable speaker.
Sep 18 2023
Lambert Luong 
QA-officer, Enraf-Nonius B.V.
Sep 18 2023
Good training. I liked both the assessments and examples provided.
Sílvia Alexandra Fernandes 
QA &RA Director, Nordeberg Medical AB
Sep 18 2023
My expectation were to understand the key steps of the processes and the challenges linked to each steps. It has been fully accomplished!
Cecile Artus-Arduise 
Head of Medical Affairs, LABORATOIRE HRA PHARMA
Sep 18 2023
Very knowledgeable person, who knows how to involve the attendants and make the subject more tangible. The quizzes force you to rehearse, remember and also apply the information that was given during the course.
Anne-Marie van Maurik
QA-manager, Enraf-Nonius B.V.
Sep 18 2023
My expectation were to understand the key steps of the processes and the challenges linked to each steps. It has been fully accomplished! The training and the speaker were very great.
Cecile Artus-Arduise
Head of Medical Affairs, LABORATOIRE HRA PHARMA
Feb 8 2022
Excellent and very informative course
Anna Gabbott 
Regulatory Affairs Specialist, Vernacare
Feb 8 2022
Excellent and very informative course
Anna Gabbott
Regulatory Affairs Specialist, Vernacare
Feb 8 2022
Very informative but also personalised
Paul Fineran
Healthcare Technology Portfolio Project and Development Manager, University of Edinburgh
Feb 8 2022
Very detailed content and patient presenters
Elena Couzens
Service Development Manager, MET Limited
Feb 8 2022
the course was well presented and clear enough for a complete beginner to understand.
Sarah Hinchliffe
Microbiology Manager, Xiros Ltd
Oct 31 2019
I learned a lot from this course, the speakers were great and they encouraged questions from the attendees. The quiz summarized each part well. My overall opinion is very positive and I would recommend it to my colleagues.
Avital Levertov 
Regulatory Affairs Manager, Elcam Medical ACAL
Oct 31 2019
It was a good course with good shared discussion about many topics and issues. The course material was well organized.
Elen Lasri
Regulatory Affairs Specialist, Elcam Medical ACAL
United Kingdom
- Advanced Healthcare Ltd Unit 2-4
- Altomed
- AstraZeneca
- BAUSCH & LOMB INC
- Bedfont Scientific
- Bespak
- Biocompatibles UK Ltd
- BSI
- Cardinal Health
- Covidien
- CPI
- Depuy CMW
- Dermal Laboratories Ltd
- Dyson
- Haleon
- Medigen Regulatory Limited
- MET Limited
- Pall Europe Limited
- Prothea Technologies
- QUINTILES CONSULTING - MTC
- Ramsay MD-Regs Ltd
- Renishaw plc
- Russell Square Quality Associates Limited
- Smith & Nephew Wound Management
- Smiths Medical International Limited
- Smiths Medical International Ltd
- Sphere Medical Ltd
- SSL INTERNATIONAL
- Summit Medical Ltd
- Systagenix Wound Management
- Terumo
- Terumo Aortic
- Tissue Science Laboratories PLC
- University of Edinburgh
- Vernacare
- Xiros Ltd
- Xiros plc
Netherlands
- BioTop Medical
- Enraf-Nonius B.V.
- Fresenius HemoCare Netherlands BV
- Mentor Medical Systems B.V.
- Merck Sharp & Dohme
- Omron Healthcare Europe BV
Sweden
- AstraZeneca AB
- Glycorex Transplantation AB
- Nordeberg Medical AB
- Q-Med AB
- Wellspect Healthcare
Denmark
- Denish Medical Devices Cert.
- LAB Research (Scantox)
- Novo Nordisk A/S
- William Cook Europe ApS
Ireland
- Abbott Vascular Devices Ireland
- Allergan Medical
- Cook Ireland Ltd
Switzerland
- RCC LTD
- SCHOTT Schweiz AG
- Synthes GmbH
United States of America
- Cardinal Health
- DEPUY
Australia
- ITL LIMITED
Belgium
- Rousselot BV
Finland
- Orion Corporation
France
- LABORATOIRE HRA PHARMA
Germany
- Angiomed GmbH & Co
Israel
- Elcam Medical ACAL
Italy
- Eurofins Biolab Srl
Pakistan
- ZAFA PHARMACEUTICALS (PVT) LTD
Run Biological Evaluation of Medical Devices Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
