Sale

Understanding Biocompatibility for Medical Devices

29 March 2022 | 2 Week Live Online Course

£990.00

Register for Module 1 | Free

Understand biocompatibility for medical devices to ensure your products are safe and compliant

Clear

Enrol before | 24 February to save £410 | 18 March to save £210

 

 

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.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

 

 

What is included in a live online course?
  • Direct access to an expert trainer
  • 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 weeks after the last session
  • Full access to the Educo Post Learning Implementation Plan (PLIP)
  • A validated certificate of attendance available for you to download and file

Learn more about how we deliver live online training

 

Key Learning Objectives

 

  • Gain a complete overview of the biocompatibility requirements in the EU and US to ensure you are compliant
  • Fully understand the ISO 10933 series and examine important parts within the series to ensure your device manages biological risk
  • Understand biological evaluations to ensure you can outsource effectively and can interpret results
  • Examine the link between biocompatibility and ISO 14971 risk management
  • Review a step by step approach to the biological evaluation process for a medical device
  • Examine the Medical Device Regulation (MDR) safety requirements in the context of biocompatibility to maintain compliance
  • Learn to interpret the requirements to identify and determine testing end-points
  • Explore material characterisation and learn how to characterise novel materials
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 Module 1
FREE to Attend | Live & Recorded

1 March  | 60 mins | 11 AM UK

Overview of biocompatibility

  • An introduction to biocompatibility
  • Biocompatibility vs biological safety

 

 

 

Register For Module 1 | Free

 

Leave this field blank
Module 2

29 March | 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

29 March  60 mins | 12 PM UK

Regulatory aspects

  • Examine the impact of the Medical device Regulation (MDR)
  • Review the impact of Brexit
Module 4

30 March | 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

31 March | 60 mins | 11 AM UK

Biocompatibility testing

  • Endpoints to be addressed in a biological risk assessment
  • GLP requirements
  • Lab selection
Module 6

4 April | 60 mins | 11 AM UK

Material characterisation

  • Physical and Chemical characterisation
  • Extractables and leachables testing – when and why?
  • Use of QSAR
Module 7

4 April | 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

5 April  | 60 mins | 11 AM UK

Global considerations for biocompatibility

  • International requirements
    • Differences in in-vivo testing interpretations – US and Europe
Module 9

6 April | 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 module 1 and Pricing

 

  • Module 1 is free to attend for this live online course and is delivered a few weeks before the start date.
  • To enrol onto module 1, please submit your email at the top of the page.
  • All sessions are recorded. If you are unable to attend module 1, you can catch up ahead of the course start date.
  • You will receive a Super Early Bird discount if you purchase the course before module 1.
  • If you decide to purchase the course after module 1, but before the start date you will receive an Early Bird Discount.

Frequently asked questions (FAQs)

 

 

Could your team benefit from this course?

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.

Or please summarise your objectives by completing the form below.

Leave this field blank
  • Choose
  • Pharmaceuticals
  • Biotechnology
  • Cell and Gene Therapies
  • Medical Devices
  • Pharma/Biotech Regulatory Affairs
  • Choose
  • I am interested in a course
  • I am looking to train a group/team of people
  • General enquiry
  • I would like to subscribe to your mail list
  • Other

*

• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.