Enrol before | 29 September To Save £400 | 20 October To Save £200
Discount has been applied to the price above. VAT, if applicable, will be added. The full price for the classroom option is £1,695 and live online is £1,495.
Course Overview
Biocompatibility assessments are essential for identifying, evaluating and managing the biological risk of medical devices. Regulators and Notified bodies must see evidence that a device follows the ISO 10993 series of standards to ensure it is biologically safe. They also want to see the biological evaluation in the wider context of ISO 14971 risk management.
This biocompatibility training course will provide you with a comprehensive understanding of biocompatibility and ISO 10993. You will understand how biocompatibility relates to risk management and safety requirements in the EU (MDR) and US (FDA). Once completed you will understand the biological evaluation process, testing end-points and material characterisation.
Interactive and engaging sessions with exercises and discussions
Bitesize learning
Access to the Educo Life Sciences Training Portal
Unlimited access to the recordings for 4 to 5 weeks after the last session
Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
A validated certificate of attendance available for you to download
What is a Hybrid Training Course?
You decide what format is best for you. The course is delivered as a classroom (in-person) course that is also delivered online. You can decide whether you would like to attend in person or online. The price is dependent on the option.
There are limited spaces on the introductory session. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.
The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. For classroom attendees, refreshments are served from 8:30 AM. For online attendees, you will receive joining instructions.
Post Learning Implementation Plan (PLIP)
Pre-course
Access to the Educo Training Portal
Submit your needs analysis and objectives for training by completing a simple online form
Action Plan
At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge
Reinforcement Session
Delivered 3 to 4 weeks after the training
It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Introductory Online Module
FREE to Attend | Live & Recorded
21 September 2023 | 60 mins | 1:00 PM UK
Delivered Online
Overview of biocompatibility
An introduction to biocompatibility
Biocompatibility vs biological safety
Register For Module 1 | Free
There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.
Day 1
21 November 2023
Introduction to the course and overview of biocompatibility
Examining the ISO 10993 series
ISO 10993 history and development
ISO 10993 structure and content
Relationship between regulatory standards
Regulatory aspects
Examine the impact of the Medical device Regulation (MDR)
Review the impact of Brexit
Biological evaluation process for a medical device
Gap analysis of existing biocompatibility data
Medical device categorization for biological risk assessment
Interactive group exercises are also included as part of the course to cement your knowledge on ISO 10993 and regulatory aspects of biological evaluations.
Day 2
22 November 2023
Biocompatibility testing
Endpoints to be addressed in a biological risk assessment
GLP requirements
Lab selection
Material characterisation
Physical and Chemical characterisation
Extractables and leachables testing – when and why?
Use of QSAR
Assessment strategies
Change Management
Use of data sources to provide chemical information
Literature searching to support safe use of materials
Global considerations for biocompatibility
International requirements
Differences in in-vivo testing interpretations – US and Europe
Gas pathway devices
Gas Pathway devices
Interactive group exercises are also included as part of the course to cement your knowledge on biocompatibility testing and assessment strategies.
Philip Clay is Director and principal toxicologist with Chorley Consulting. He is a registered toxicologist and specialises in product safety assessment with over 30 years’ experience. He has published and presented widely in his expert field of genetic toxicology and in the wider area of safety assessment. Phillip has recently joined the BSI Ch/194 Committee to provide UK input to ISO/Tc 194 and CEN/TC 206 for standards relating to biological evaluation of medical devices.
Janine Townsend
Janine is a Senior Safety Assessor with Chorley Consulting. She holds a MSc in Global aquatic biodiversity and a BSc in Molecular biology and biotechnology, both from the University of Hull. She has over 10 years of regulatory and product safety experience within FMCG and the Fragrance industry. She is an experienced project manager and is also our Quality Manager developing and maintaining our ISO 9001 quality management system. Janine brings to Chorley knowledge in the regulatory arena as well as toxicological data analysis skills for use in the risk assessment of medical devices.
Rona Middlemiss
Rona is a Senior Safety Assessor with Chorley Consulting. She holds a first class MSci in Biomedical Sciences from the University of Aberdeen. Additionally, she has attended training courses on the Practical Application of Toxicology in Drug Development and also Personal Animal License Course, Modules 1-3. She spent her year industry with a multinational consumer healthcare and medical device manufacturer, gaining experience in the safety assessment of medical devices. She joins Chorley from a Scientist role with British American Tobacco where she honed her toxicology skills performing toxicological risk assessment for harm reduction products. Rona brings to Chorley experience gained with a healthcare medical device manufacturer as well toxicological risk assessment skills gained during her time with 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.
This course is suitable for professionals who must have a good understanding of biocompatibility. It is suitable for professionals who work in areas and would benefit from a deeper understanding of biological evaluations. These include:
Regulatory Affairs
Design & Development Professionals
Clinical Professionals
Risk Management Personnel
Quality Personnel
Engineering Professionals
Most of our classroom courses are located at a venue in central London. The city has good transport links and is good place to socialise with fellow attendees. Accommodation is not included in the price. We recommend staying in a hotel within walking distance of the venue. Lunch and refreshments are included on all days where you will be able to interact with fellow peers and the trainers.
The course is held in the following venue:
Cavendish Conference Centre, 22 Duchess Mews, London, W1G 9DT
Submit your needs analysis and objectives for training by completing a simple online form
Action Plan
At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge
Reinforcement Session
Delivered 3 to 4 weeks after the training
It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Introductory Module 1
FREE to Attend | Live & Recorded
| 60 mins | 11 AM UK
Overview of biocompatibility
An introduction to biocompatibility
Biocompatibility vs biological safety
Register For Module 1 | Free
There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.
Module 2
| 60 mins | 11 AM UK
Examining the ISO 10993 series
ISO 10993 history and development
ISO 10993 structure and content
Relationship between regulatory standards
Module 3
60 mins | 12 PM UK
Regulatory aspects
Examine the impact of the Medical device Regulation (MDR)
Review the impact of Brexit
Module 4
| 60 mins | 11 AM UK
Biological evaluation process for a medical device
Gap analysis of existing biocompatibility data
Medical device categorization for biological risk assessment
Module 5
| 60 mins | 11 AM UK
Biocompatibility testing
Endpoints to be addressed in a biological risk assessment
GLP requirements
Lab selection
Module 6
| 60 mins | 11 AM UK
Material characterisation
Physical and Chemical characterisation
Extractables and leachables testing – when and why?
Use of QSAR
Module 7
| 60 mins | 12 PM UK
Assessment strategies
Change Management
Use of data sources to provide chemical information
Literature searching to support safe use of materials
Module 8
60 mins | 11 AM UK
Global considerations for biocompatibility
International requirements
Differences in in-vivo testing interpretations – US and Europe
Module 9
60 mins | 11 AM UK
Gas pathway devices
Gas Pathway devices
Philip Clay is Director and principal toxicologist with Chorley Consulting. He is a registered toxicologist and specialises in product safety assessment with over 30 years’ experience. He has published and presented widely in his expert field of genetic toxicology and in the wider area of safety assessment. Phillip has recently joined the BSI Ch/194 Committee to provide UK input to ISO/Tc 194 and CEN/TC 206 for standards relating to biological evaluation of medical devices.
Janine Ingleby
Janine is a Senior Safety Assessor with Chorley Consulting. She holds a MSc in Global aquatic biodiversity and a BSc in Molecular biology and biotechnology. She has over 10 years of regulatory and product safety experience within FMCG and the Fragrance industry. Janine brings knowledge in the regulation of cosmetics and fragrances as well as toxicological data analysis skills for use in risk assessments of medicines, medical devices, cosmetics and general products. She has been actively monitoring the impact of Brexit on the requirements for medical devices in the UK.
Katherine Torrance
Katherine is a Senior Safety Assessor with Chorley Consulting. She holds a BSc in Biomedical Sciences and an MSc in Translational Oncology. She has worked within the health sector in both the NHS and in industry for several years gaining product safety experience working with medicines and medical devices. She is an experienced MedDRA coder and is a skilled medical writer. She has extensive experience in the assessing of biological safety of a range of medical devices. Alongside her knowledge of biocompatibility, she has attended training on EU MDR implementation and has prepared numerous biological safety assessments ready for MDR submission. Katherine brings skills in literature and data searching as well as analysis skills for use in risk assessment of medicines, medical devices, cosmetics and general products.
This course is suitable for professionals who must have a good understanding of biocompatibility. It is suitable for professionals who work in areas and would benefit from a deeper understanding of biological evaluations. These include: Regulatory Affairs | Design & Development Professionals | Clinical Professionals | Risk Management Personnel | Quality Personnel | Engineering Professionals.
Free Online Module and Pricing
Module 1 is free to attend and is delivered online and is recorded.
To enrol onto module 1, please submit your details in the form.
Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
There are price tiers for this course. The dates of these are at the located above the course overview.
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
Complete our contact form by following the link. Get in touch.
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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• In the event we do not have enough people on one of the options we will contact you to discuss switching. If for example we ask you to switch from classroom (in-person) to live online, we will refund you the difference in price.
