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Biocompatibility for Medical Devices

This intensive 8-hour virtual course provides a practical, risk-based approach to medical device biocompatibility in accordance with ISO 10993. Participants will learn to navigate the journey from material selection and Biological Evaluation Plans (BEPs) to finalising Biological Evaluation Reports (BERs) for regulatory submission.

Full Cost: €495 per person            Subsidised Rate: €395 per person

€395.00 per person Booking

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Biocompatibility for Medical Devices

Course Overview

Developed for professionals in Regulatory Affairs, Quality Assurance, and Product Development, this course explores the "how-to" of biocompatibility. Using a solution-focussed approach, the training integrates the design process with lifecycle management to ensure device safety and performance.

Learning Outcomes

By the end of this course, you will be able to:

  • Integrate biocompatibility evaluation within the product development and lifecycle management process.
  • Assess device type, intended use, and contact duration to determine biological safety needs
  • Apply ISO 10993 guidance to select appropriate biological evaluation tests
  • Develop comprehensive Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs)
  • Understand the importance of extractables and leachables data within a biological evaluation.

Course Agenda

Day 1: Fundamentals & Planning

  • Governing regulations and the regulatory strategy.
  • Recent updates to ISO 10993 and their impact.
  • Risk assessment and risk management in biological evaluation.
  • Developing Biological Evaluation Plans (BEPs).

Day 2: Testing & Documentation

  • Extractables and leachables in biological evaluation.
  • Selection of testing strategies under ISO 10993 compared to FDA expectations.
  • In vivo vs. in vitro testing: Practice, interpretation, and limitations.
  • Developing Biological Evaluation Reports (BERs)

 

Course Details

  • Duration: 8 hours total, spread across two half days.

  • Delivery Mode: Virtual instructor-led training.

  • Full Cost: €495 per person.

  • Subsidised Rate: €395 per person (Available via the Irish Medtech Skillnet subsidy).