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Biocompatibility for Medical Devices

Learn how to navigate the regulatory landscape of biocompatibility testing for medical devices. This course offers a clear, practical introduction to biocompatibility assessment in accordance with ISO 10993 and related global standards. Designed for professionals working in medical device development, quality, and regulatory affairs, the program also highlights FDA guidance and how it aligns with ISO requirements.

Participants will:
  • Gain a working understanding of Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs)
  • Learn how to select and interpret biocompatibility tests, including in vitro and in vivo methods
  • Understand the risk management process per ISO 14971
  • Explore how extractables, leachables, and material characterization influence testing strategy
  • Review quality standards such as GLP and ISO 17025 as they apply to biological safety testing

Led by an industry expert with hands-on regulatory experience, this training takes a practical, problem-solving approach to help you apply what you learn immediately.
Thank you!
Date: 14th - 15th April, 2026 (2 half days)
Time: 13:00 - 17:00 BST | 8:00 - 12:00 EDT

What's included?

  • Your own learning portal
  • Course recordings
  • Live sessions
  • PDF materials
  • Certificate of completion
  • Access to a community

Learn with a community

Social learning is a powerful tool that enables individuals to learn from each other through observation, communication, and collaboration.

Using our community, people can more efficiently acquire new knowledge, skills, and behaviors.

Assessments & Feedback

Assessments and feedback are essential components of the learning process, offering valuable insights into progress.

All of our courses use knowledge checks and practical peer learning throughout to reinforce understanding. 
- Meet the trainer 

Richard Young

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Richards’ core skills can be broadly divided into 4 main areas
- Regulatory Affairs
- GMP (Quality Assurance)
- GLP (Laboratory Testing)
- GCP (Clinical)
These core skill areas have been developed over 25 years of experience with products
ranging from class 3 devices such as Orthopedic implants (IIb) neurological robots,
through electromedical devices such as infusion systems and cardio vascular products.

Richard brings a blend of pragmatism and experience to these disciplines that facilitates
insightful problem solving approaches as well as solid solutions.

Richard has also had broad experience in a wide range of materials and manufacturing
technologies including sterilisation, plastic moulding, software development, electronic
medical devices, ceramics, CNC machining, plasma coatings, packaging, extrusion and
automated assembly.

Let's discuss your 
training needs. 

We aim to respond to you within 24 hours. 

Opening Hours:
Monday - Friday: 9:00am - 5:00pm
Saturday - Sunday: Closed
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Frequently asked questions (FAQs)

Who should attend this course?

This course is designed for professionals working in regulatory affairs, quality assurance, product development, or toxicology who are involved in the testing, evaluation, or approval of medical devices. It’s also valuable for anyone looking to better understand biocompatibility requirements under ISO 10993 and FDA guidance.

How will this course help ?

This course will help participants build a clear, practical understanding of biocompatibility requirements for medical devices. It provides the knowledge needed to plan and interpret biological evaluations, align with ISO 10993 and FDA expectations, and make informed decisions about test selection, risk management, and compliance.

Will I receive a certificate after the course? 

Upon successfully completing this training, you will receive a digital certificate. This certificate can be used to showcase your knowledge to employers and Notified Bodies.