Course Description

Biocompatibility of Medical Devices

Course Description:

This course introduces biocompatibility, a relatively new and complex field involving heterogeneous biomaterials and medical devices. This course focuses primarily on the biological evaluation of the safety of materials, a complex task requiring knowledge of medicine, biology, pathology, engineering, and material science.

The course slideshow provides insight into normative requirements and manufacturing responsibilities concerning medical device development for patient use. It discusses the guidelines for product testing and gives a general description of various testing procedures.

Watch the Course Trailer:

 

 


Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Teach participants how to use ISO standards to establish a biological safety evaluation plan compatible with a device’s nature and its duration with body contact
  • Identify the manufacturing responsibilities concerning the evaluation of biological risk
  • Acknowledge that the manufacturer must rely on the expertise of agencies, competent authorities, market requirements, and existing historical data in order to ensure an strong investment in biocompatibility
  • Differentiate the various types of in vitro and in vivo biocompatibility tests
  • Recognize that animal studies should only be performed when the required information is essential to characterizing test material and when no other suitable scientifically-validated in vitro test method is available

Who Should Enroll:

Developmental engineers, R&D department employees, quality and regulatory affairs employees, and those that need a working knowledge of biocompatibility are all encouraged to enroll in this course.


Prerequisite Knowledge/Requirements:

A general understanding of quality assurance, research and development, and biology is required for this course.


Subject Matter Expert:
Christine Von Gunten
Gilles Farron

Duration:
50 min

Release date:
07/29/2013

Related resources:
Yes

Case studies:
No

Price:
Basic Account: € 151.00
Premium Account: € 113.00

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