Biological Equivalence from a Biocompatibility Perspective - Advanced Level
In this course we will establish an understanding of the equivalency concept and some potential pitfalls that await manufacturers when using this approach
Course objective and outcome
This course focuses on the concepts of evaluating medical devices from a biocompatibility perspective using the concepts of equivalency. Equivalency is mentioned in ISO 10993-1:2018 and in ISO 10993-18 which become the primary references for using equivalency in the biological evaluation process. What is not so clear by reviewing these standards is how the concepts are recognized or accepted by regulators like Notified Bodies and the FDA.
In this course we will establish a fundamental understanding of the equivalency concept and some potential pitfalls that await manufacturers when using this approach. As with most things, understanding the strengths and weakness of a method assists one to refine the approach used.
This course will use a training presentation to lay the groundwork and understanding of equivalency followed by workshops and case studies to provide practical experience of using the concepts presented. The course will be interactive so questions are welcome throughout the day but time will also be dedicated for Q&A.
Use of Biological Equivalence as Part of the Biocompatibility Evaluation
- Understand the basis for the concepts of biological equivalence
- Learn the different types of equivalency that factor into overall biological equivalence
- Discuss different ways that equivalency may be established
- Understand how biological equivalence expectations can vary based on different types of device exposure
- Discuss different types of changes to devices and how equivalency may factor into addressing the changes
- Changes in formulation e.g. additives or materials
- Changes in manufacturing
- Changes in suppliers
- How does information from suppliers and vendors factor into the assessment
- Best practice for supplier initiated changes
- Present case studies as examples of equivalency being used and challenges from regulators
- Use examples in workshops for attendees to apply the concepts presented and then discuss a potential solution presented by the trainer
The course format is a combination of online and onsite training meaning the participants will meet physically at Medicoindustrien in Hørsholm and receive the training online on a big screen transmitting the trainer directly from NAMSA, USA.
Who should attend
This course is targeted towards those who have a working knowledge of biocompatibility and are looking to update and sharpen their skills.
- Biosafety specialists
- Biocompatibility specialists
- Material specialists
- Risk managers
- Regulatory specialists and managers
- Product design engineers
- Design control specialist
- Quality assurance specialists and managers
Don Pohl, Principal Product Development Strategist, NAMSA