Biocompatibility and Toxicological Risk Assessment of Medical Devices: The Notified Body Perspective

This one-day training program aims to provide participants with insights into ISO 10993-1:2018 and ISO 10993-17:2002 standards. The participants receive a hands-on understanding of the biocompatibility assessment, testing strategy and toxicological risk assessment approach required for demonstrating compliance with the standard requirement.

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

• Categorizeand classify the medical device based on contact and duration
• Testingstrategies for a medical device
• Determine allowable limits of substances Extractable/leachable out of medical devices
• Conduct risk evaluation of hazardous substances present in medical devices

• Basics of Biocompatibility
• What are the different testing strategies?
• Creating a medical device testing strategy
• Latest updates on revised standards
• Biocompatibility Assessment – The Notified Body Perspective – ISO 10993-1:2018
• Toxicological Risk Assessment according to ISO 10993-17:2002
• Establishing allowable limits of leachable substances
• Exercise
• Online examination

Research

• Product developers
• Toxicologists
• R&D team members
• Regulatory managers
• Quality Assurance personnel

Engineering/Administration

• Engineers
• Operational managers
• Manufacturing managers
• Service providers associated with the medical devices industry.

Participants having basic knowledge in Medical Devices and Biocompatibility or holding an experience in pharmaceutical toxicological evaluations are preferred.

Our training partners are experts in the industry, having hands-on experience in conducting live virtual/classroom training programs, in-depth knowledge of the standards and regulations that affect your business and applying these standards across various industry domains. Our training partners do their best to provide the best learning experience.

• Capabilities to create biocompatibility testing strategies for medical devices
• Capabilities to establish allowable limits of leachable substances
• Understanding the notified body perspective with respect to the assessment of medical devices

The Biocompatibility and Toxicological Risk Assessment of Medical Devices Training Certification can be obtained by enrolling and attending our instructor-led training program. After completion of the course, participants must attend an examination containing multiple choice questions to obtain the certificate. Participants scoring as per the passing criteria would be awarded a successful completion certificate by TÜV SÜD South Asia.

Examination Pattern

• Exam Type: Multiple choice questions
• Exam Questions: 50
• Exam Time: 60 minutes
• Required number of points: 30 points
• Maximum number of points: 50
• Aids: Open Book
• Passing Criteria: 60%

1. Are there any prerequisites to apply for the course?
Candidates are recommended to have prior experience in relevant fields applicable as per the training program.

2 How does the Biocompatibility and Toxicological Risk Assessment of Medical Devices Training help me?
The one-day training helps quality and regulatory candidates thoroughly understand ISO 10993-1:2018 requirements. It is interactive with exercises and assignments to provide practical knowledge applicable to their work.

3. Can I get the course content?
We share the training content with all participants before the start of the training.

4. Can I get the recording of the sessions?
These are all live and interactive training sessions. Recording of the training sessions is not permitted.

5. When does the final examination take place?
The final exam access is sent to your email on the last training day and remains valid for 72 hours. Participants must submit the exam within this time, or it will count as their first attempt.

6. How long does it take to get the e-certificate?
Once you have submitted the final examination, it is sent for evaluation. General evaluation requires three weeks to be completed. The results, followed by the e-certificate, are released after the due evaluation is completed.

7. How can I get the physical copy of the e-certificate?
We provide a physical copy of the e-certificate at an additional charge. You may email us requesting a physical copy after receiving the e-certificate.

8. Can I take the examination without attending the course?
As per the guidelines, participants are required to attend the complete training to be eligible for the final examination.

9. What if I fail the examination?
Participants are eligible to take a second attempt if required. The second attempt at the final examination is provided at an additional charge. You may email us in case you are required to appear for a second attempt for the final examination.

10. How do I register?
You may register by paying the training fees on the e-Store. Following this, you will receive a confirmation about your enrollment in the preferred batch.

11. Is there any refund policy for the paid fees?
Please refer to Cancellation and Refund policy page.

• Stryker Corporation
• Boston Scientific
• Draeger India Pvt. Ltd.
• Medtronic India Pvt. Ltd.
• Tata Consultancy Services
• Meril Healthcare Pvt. Ltd.
• Thermo Fisher Scientific
• HCL Technologies Ltd.
• Siemens Healthineers
• Becton, Dickinson & Company