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Starting 2 November 2020

4-week online academy

Deepen your understanding of ISO 10993-1 so you can apply a risk-based approach to your biocompatibility studies

Course Overview

Within medical devices, biocompatibility assessments are essential in the early stages of development to safeguard patient safety. Notified Bodies must see adequate data on biocompatibility (in accordance with ISO 10993) to be sure a device is biologically safe. 

Over four weeks this course will provide you with a baseline understanding of key requirements under ISO 10993 and what you need to include in an evaluation to ensure compliance. In addition, you will be able to understand biocompatibility in the context of risk management, and safety requirements under the Medical Device Regulation (MDR) and from a global perspective, cemented by a series of case studies.

Online Academies

MDTI online courses are on-demand digital courses developed by our expert faculty providing learning on a range of technical topic areas.

Over 4 weeks students will learn through:

  • 7 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisiting the content with unlimited access to all the materials for 3 months
  • Participating in the discussion forum to interact with other students
  • Interacting with the trainer through the forum during the course
  • Additional content such as materials and white papers available to download

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact

What will you learn?

ISO 14971
ISO 14971

Understand the relationship between biocompatibility testing and ISO 14971

ISO 10993-1
ISO 10993-1

Analyse ISO 10993-1 and its updates

Material characterisation
Material characterisation

Explore material characterisation in its different forms

MDR and biocompatibility
MDR and biocompatibility

Examine the MDR safety requirements in the context of biocompatibility

EU and FDA regulations
EU and FDA regulations

Recognise the differences in the EU MDR and FDA 510(k) approaches

Who is this course for?

This course will be useful for anyone new to biocompatibility for medical devices, who would like a refresher of this material or to update their understanding of regulations, including:

  • Regulatory Affairs
  • Quality Assurance
  • Manufacturing, development and design
  • Toxicology
  • Process development

Find out more about online academies...

MDTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

On average, delegates of our online academies said...

for quality of content
applied content during the course to their role
for quality of delivery

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.

25% discount on Routledge books

As a student on the course you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge website

Examples of books and eBooks within medical devices include:

  • ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition
  • ISO 9001: 2015 - A Complete Guide to Quality Management Systems
  • Medical Device Quality Assurance and Regulatory Compliance
  • Design Controls for the Medical Device Industry, Third Edition
  • And more