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

Biocompatibility is the biological evaluation of Medical Devices in compliance with the standard ISO 10993-1: 2025. According to ISO 10993-1:2025, Biological evaluation refers to the systematic process used to assess and document biocompatibility, including the assessment of material interactions with tissues, categorization of devices by contact type and duration, and implementation of a risk-based approach to determine necessary testing and gap analysis.

Regulators require comprehensive biocompatibility assessments aligned with ISO 10993 standards, including a Biological Evaluation Plan (BEP), chemical characterization per ISO 10993-18:2020, and toxicological risk assessment following ISO 10993-17:2023. Together, these justify a device’s safety scientifically.

This training covers biocompatibility principles, regulatory requirements, evaluation processes, material characterization, risk assessment methods, toxicological evaluation, biological effect testing overview, test item selection, and report preparation, equipping participants to manage biocompatibility throughout product development and regulatory review. Join us and start your career in regulatory affairs!

(DAY 1)

Section 1 – Introduction to regulatory requirements applicable for biological evaluation

• Regulatory background
• The EN ISO 10993 series
• Vertical biocompatibility standards

Section 2 – Biological evaluation

• Device categorization
• Endpoint identification
• Physical and chemical characteristics
• Existing data for risk assessment
• Biological testing
• Biological safety evaluation
• Test item selection and sample preparation

Section 3 – Chemical characterization and toxicological assessment

• Chemical characterization
• Extraction parameters
• Analytical Methods
•  The analytical evaluation threshold
• Output from the chemical characterization
• Toxicological Risk Assessment
• Exercises and activities

(DAY 2)
Section 4 – Biological Testing and Endpoint Evaluation

• EN ISO 10993-2 fundamentals
• Biological endpoint testing
• Knowledge check
• Endpoint evaluation
• Special topics for consideration during biological testing
• Applicable MDR clauses
• Knowledge check
• Common pitfalls
• Take-home messages
• Exercise and activities

Candidates working in below domains should attend this training:

• Medical device manufacturers
• Quality Assurance, Regulatory Affairs, Research & Development
• Toxicologists working on biocompatibility studies
• Internal and external auditors
• Consultants and implementation specialists
• Master’s or PhD students pursuing biomedical engineering, materials science, pharmacy, toxicology or regulatory science
• Engineers and Service Providers to the industry

• Participants are recommended to have a basic understanding of medical devices and biocompatibility concepts, or prior experience in toxicological evaluations related to medical devices. Familiarity with regulatory frameworks and quality systems in the medical device industry is beneficial but not mandatory.
• Participants are required to attend and complete the full training to be eligible for the final examination and the certification thereafter. This foundation will help attendees fully engage with the course content and apply the learning effectively in their roles.

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.

Advance your career with knowledge that bridges scientific understanding and regulatory insight, essential for success in the evolving medical device landscape.

This training equips professionals and academics with practical skills in biocompatibility standards, toxicological risk assessment, and regulatory compliance. Participants will gain a recognized certification and expertise valuable for roles in quality assurance, regulatory affairs, research, and clinical evaluation.

By completing this course, attendees will be able to:

• Effectively identify relevant parts and apply ISO 10993 series standards in product development and regulatory submissions
• Lead or support biocompatibility and safety evaluations with foundational knowledge and practical insights that support advanced research, teaching, and collaboration with industry and regulatory bodies.
• Enhance qualifications for roles such as Biocompatibility Engineer/Expert/Specialist, Regulatory Affairs Manager, Quality Engineer, and consultant or research scientist. Participants also benefit from expert-led discussions and networking opportunities, fostering professional growth and future career pathway.

• Learners are eligible to undertake an online examination on completing the full training.
• Classroom exercises will be spread across 2 days of the training.
• Learners are required to successfully complete the final examination to be eligible for the certification.
• Examination is conducted online and will consist of scenario-based multiple-choice questions.
• Exam duration: 60 minutes
• Passing criteria: 70%

Learners who pass the final examination are awarded a successful completion certificate by TÜV SÜD South Asia which mentions that the candidate has passed the final examination.

1. When can I get the certificate?

Certification for the Biocompatibility & Toxicological Risk Assessment of Medical Devices Training will be issued within 14 working days from the date of exam submission.

2. When can I get the training material and invite?

Taining materials, invitation and other details are shared after completing the prerequisites.

3. How do I pay the fees for training and examination?

Online mode

4. What are the benefits of the Biocompatibility & Toxicological Risk Assessment of Medical Devices Training?

The Biocompatibility & Toxicological Risk Assessment of Medical Devices Training is a two days training which equips professionals with practical skills in biocompatibility standards, toxicological risk assessment, and regulatory compliance. It will help you lead or support biocompatibility and safety evaluations with foundational knowledge and practical insights that support advanced research, teaching, and collaboration with industry and regulatory bodies.

5. What if I fail in the final examination?

Participants are permitted to take two attempts to the final examination. The second attempt to the final examination is provided on a chargeable basis. Please write to us via email requesting for a second attempt to the final examination.

6. 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