Biocompatibility Testing: What You Need to Know

The objective of the Seminar is to teach participants how to use the current ISO 10993-1 and FDA standards to establish a Biological safety evaluation plan, including how to document and implement their plan. Participants will not only learn how to assess their device for Biological risks but also understand when testing is not necessary. We will also cover how to properly document these findings and fill out a Biological evaluation report. Why Should You Attend: All medical devices that have direct or indirect contact with the human body require an assessment of the Biocompatibility of the materials used to manufacture the device, with the test schedule depending on the nature and duration of body contact. Domestic and international regulatory bodies emphasize the use of risk-based approaches to assess Biocompatibility. Who will Benefit: Anyone with a desire to be up to date with the current state of the art of Biocompatibility assessment. Medical device, pharmaceutical, a... Read more

The objective of the Seminar is to teach participants how to use the current ISO 10993-1 and FDA standards to establish a Biological safety evaluation plan, including how to document and implement their plan. Participants will not only learn how to assess their device for Biological risks but also understand when testing is not necessary. We will also cover how to properly document these findings and fill out a Biological evaluation report. Why Should You Attend: All medical devices that have direct or indirect contact with the human body require an assessment of the Biocompatibility of the materials used to manufacture the device, with the test schedule depending on the nature and duration of body contact. Domestic and international regulatory bodies emphasize the use of risk-based approaches to assess Biocompatibility. Who will Benefit: Anyone with a desire to be up to date with the current state of the art of Biocompatibility assessment. Medical device, pharmaceutical, and combination product start up and established companies.