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Understanding Biocompatibility for Medical Devices

23 & 24 October | Hybrid Training | London

£1,195.00 – £1,395.00

(19 customer reviews)

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

 

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Register For Module 1 | Free-To-Attend

 

Module 1 of this course is free to attend and delivered online. Register to receive joining instructions for the live event, recording and presentation slides.

Register Early To Save

 

Enrol before | 30 August To Save £400 | 27 September 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 £1,595 and live online is £1,595.

Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

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 classroom and live online training. If you have any concerns about COVID-19 before registering on to the course, please read our COVID-19 commitment.

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

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. If you cannot make the in-person course, you can attend online. The price is dependent on the option.

 

We recommend visiting our website to learn more. Click here to learn more about hybrid training at Educo Life Sciences.

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

23 & 24 October 2024

2-Day Hybrid Training

Register at the top of the page, selecting either classroom or live online.

14 & 15 May 2025

2-Day Hybrid Training

Register at the top of the page, selecting either classroom or live online.

18 & 19 November 2025

2-Day Hybrid Training

Register at the top of the page, selecting either classroom or live online.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Free Online Module

 

  • Module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
  • To register for module 1, please submit your details in the form located in the agenda.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.

 

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered either online or in a classroom. Please check which course format you have booked.
  • For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)

Hybrid Training Information

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. 

Live Online Training Information

The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. 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

5 September | 1:00 PM UK | 60 mins

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.

By clicking register, you agree to our Privacy Policy

Day 1

23 October 2024

14 May 2025

18 November 2025

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

23 October 2024

15 May 2025

19 November 2025

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.

Annette Callaghan | 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).

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:

Hallam Conference Centre, Cavendish Venues, 44 Hallam St, London, W1W 6JJ

 

Link to the Google Map

19 reviews for

Understanding Biocompatibility for Medical Devices

23 & 24 October | Hybrid Training | London

  1. Oxsonics (verified owner) –

    n/a

  2. ZImmer Biomet (verified owner) –

    n/a

  3. Individual Booking (verified owner) –

    n/a

  4. ISDIN –

    I had no experience in medical device. This course has served me as a starting point to have a basic knowledge about how to do the biological development of the safety of a medical device.

  5. ISDIN –

    n/a

  6. Zimmer Manufacturing GmbH (verified owner) –

    Broad understanding of International standards requirements for biological evaluation and effective tools provided for their applicability in ensuring compliance for medical devices.

  7. Saudi Food and Drug Authority (SFDA) –

    N/A

  8. Saudi Food and Drug Authority (SFDA) –

    N/A

  9. Summit Medical Ltd –

    N/A

  10. Bedfont Scientific Ltd –

    For anyone in the future who needs biocompatibility training, I will recommended Educo/ Chorley. The two instructors Rona and Janine were so informative and were able to answer all questions thrown at them. The Cavendish Centre were amazing with hospitality, lovely food, and always topping up drinks for our breaks.

  11. Bedfont Scientific Ltd –

    Incredibly informative with very knowledgeable trainers. Would highly recommend to anyone responsible for co-ordinating biological evaluations and biocompatibility testing.

  12. ZuriMED Technologies AG (verified owner) –

    N/A

  13. Vitreq (BVI Medical) –

    Very well explained training

  14. Zimmer Biomet (verified owner) –

    Highly recommended. Good overview of ISO 10093 with current relation to MDR as well as to other international standards. Nice given examples to sum up your knowledge. Friendly atmosphere and competent tutors.

  15. Vitreq (BVI Medical) –

    Educo’s online course on “Understanding Biocompatibility for Medical Devices” was well-organized. Communication was clear at all stages, the training portal provided all the information and instructions, and the live sessions were presented by knowledgeable professionals.

  16. Vitreq (BVI Medical) –

    Great course for general understanding and the expectancy from notified bodies. Thank you so much for the clear presentations.

  17. Innoviamedical –

    Really enjoyed, The trainer was very knowledgeable and happy to help. Very engaging and easy to understand.

  18. Alliance Pharma –

    It was an excellent course and I’ve learnt a lot I would definitely recommend the course to my colleagues.

  19. Endomagnetics Ltd –

    The training course was very informative and provided valuable insight into important considerations for current and future projects

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