TRAINING & EVENTS

Boost Your Career with the Introduction to Biocompatibility Course and Certification in Biocompatibility Evaluation

Learn the fundamentals of biocompatibility, including FDA guidelines, testing strategies, and reporting examples, through expert-led training and practical workshops.

91%

of FDA-trained professionals reported improved ability to navigate and apply ISO 10993 guidelines and biocompatibility review tools after course completion

84%

of biosafety professionals reported increased preparedness in identifying and mitigating risks associated with high-risk research, including ePPP and DURC protocols, following structured biocompatibility and risk training

Start Your Introduction to Biocompatibility Training Today

Let’s Talk!

Why Biocompatibility Certification Matters

Biocompatibility evaluation isn’t just about compliance; it’s about ensuring medical devices are safe and effective for patients worldwide.
Whether understanding FDA biocompatibility guidelines or exploring real-world examples, certification ensures you’re prepared to tackle the industry’s most pressing challenges.

Certificate of completion

Career Growth

Certification in biocompatibility opens doors in regulatory affairs, R&D, and quality assurance.

Efficiency

Learn risk-based strategies to streamline biological evaluations, saving time and resources.

Global Standards Expertise

Gain the skills to meet ISO 10993 biocompatibility requirements.

Program Overview

Our biocompatibility training program integrates in-depth knowledge paired with hands-on practice, equipping participants with usable, real-world skills.

Comprehensive Content

Gain the skills to meet ISO 10993 biocompatibility requirements.

Global Perspective

Addresses compliance needs across geographies, including FDA and ISO standards.

Interactive Learning

Includes case studies and group discussions, ensuring participants can confidently interpret biocompatibility report examples.

DAY 1

Fundamentals and Risk-Based Approaches

Risk-based approaches to biological evaluation.
Introduction to biocompatibility testing and FDA requirements.
Group activity: Create a biological evaluation plan.

DAY 2

Advanced Applications and Compliance

Analyzing test results examples for FDA and EU MDR and preparing BERs.
Addressing challenges in emerging markets and personalized medicine.
Group discussions on cross-disciplinary collaboration.

Customization Options

Tailored training to address specific needs, such as Extractables & Leachables (E&L) or personalized medicine.

How to Get Certified

1. Attend the Course

Join two days of expert-led sessions and interactive workshops.

2. Pass the Exam

Complete the certification test within 60 days of finishing the training.

3. Show Off Your Success

Share your certification with peers and on LinkedIn to showcase your achievement.

Real-World Outcomes from Biocompatibility Training

Leadership roles

Majority of participants hold middle positions, leveraging the training to enhance their expertise in regulatory compliance and risk management.

Skill development

Attendees gained advanced knowledge in creating Biological Evaluation (BE) and aligning with ISO 10993 standards, improving compliance workflows.

Operational efficiency

Risk-based strategies learned during the training helped organizations streamline evaluations and reduce unnecessary testing costs.

Career advancement

Certification signified advanced expertise, helping participants stand out in regulatory and quality assurance roles.

Hands-on learning

Workshops and case studies provided practical tools to address real-world compliance challenges.

Regulatory success

Improved proficiency in compliance processes led to better approval rates and faster project timelines.

Where Are They Now?

Berkshire,
United Kingdom

Tienen,
Belgium

Macquarie Park,
Australia 

Vienna,
Austria

Munich,
Germany

Salt Lake City
United States

Glemboux,
Belgium

Virginia Beach,
United States

Certification and Career Growth

+20-25% Salary Increase for Certified Professionals

Certified biotech professionals earn more than their non-certified counterparts.

Source: Payscale, Greatness.bio Biotech Job Board

30% Faster Time-to-Market for Medical Device Projects Managed by Certified Professionals

Streamlined compliance processes reduce delays in approvals.

Source: NAMSA

70% of Certified Professionals Experience Career Advancement Within One Year

Certifications lead to measurable career progression.

Source: Industry trends and Greatness.bio

95% of Participants Report Enhanced Problem-Solving Skills for Biological Safety Evaluations

Certifications lead to measurable career progression.

Source: Biorisk Management Workshop Data

Biocompatibility Testing and Regulatory Impact

Over 235,000

Biocompatibility Tests Conducted Annually by NAMSA

Reflecting the high demand for safety
evaluations.

Source: NAMSA data

118,000+

Medical Device Tests Conducted
Annually by NAMSA

Comprehensive evaluations ensure safety and compliance.

Source: NAMSA data

95%

On-Time Turnaround for Biocompatibility Testing at NAMSA Labs

Ensures timely support for product development.

Source: NAMSA data

Events and Networking Opportunities

Certification is just the beginning! The Biocompatibility Training Program connects you to a thriving community of peers, mentors, and industry experts. Regular events keep you informed about the latest trends, techniques, and regulations, ensuring your skills stay sharp.

Stay connected and get the latest updates, insights, and opportunities —follow the IMG LinkedIn Page to stay in the loop.

Receive invites to webinars, conferences, and specialized workshops.

Collaborate with professionals worldwide to exchange ideas and best practices.

Upcoming Events

Subscribe to our newsletter and stay updated with all the important news!

Past Events

Toxicology for Biological Evaluation Course

DECEMBER 14, 2024

Toxicology for Biological Evaluation Course

Equip with the skills to establish and critically assess Extractables and Leachables in medical devices.

RAPS Euro Convergence 2025

FEBRUARY 02, 2025

RAPS Euro Convergence 2025

Equip with the skills to establish and critically assess Extractables and Leachables in medical devices.

Frequently Asked Questions (FAQ)

Got questions? We’ve gathered answers to help you make an informed decision about enrolling in the Biocompatibility Training Program.

  • A specialized course designed to teach professionals the principles of biocompatibility, including biological evaluation of medical devices, FDA and ISO 10993 guidelines, and the creation of Biological Evaluation Plans (BEP) and Reports (BER).

  • Ideal for professionals in R&D, regulatory affairs, quality assurance, and toxicology who want to enhance their expertise in biocompatibility testing and biological risk assessment.

  • This certification stands out for its focus on FDA, EU MDR, and ISO 10993 requirements, combined with hands-on workshops, real-life case studies, and practical examples that prepare you for global compliance challenges.

  • Yes! The program offers hybrid learning options, flexible timelines for the certification exam, and resources designed to fit the schedules of working professionals.

  • The fee includes two days of live training sessions, access to course materials, hands-on workshops, and one attempt at the certification exam.

  • Get started by visiting our Contact Us page. A team member will follow up to help you secure your spot in the next session and provide all the details you need, including the course schedule and materials.

Take charge of your career with expert biocompatibility training. From understanding ISO 10993 series and FDA guidelines to analyzing product examples, this program gives you the tools to succeed.