Trainings and Events
Continue Your Education with the Experts at IMG
With Intrinsic Medical Group, you have the opportunity to enhance your professional skills through our continuing education courses in biocompatibility. Whether you’re looking to deepen your expertise or stay updated on the latest industry standards, our courses are designed to meet your needs. Inquire with our team to see how we can be of service for your particular industry or conference – our trainings make for valuable additions to your program. Additionally, we invite you to join us at one of our events, where you can network with peers and gain valuable insights. Inquire today to learn more about how you can participate!
Intrinsic Medical Group Certifications
Develop skills for interpreting and summarizing raw data from external
Gain hands-on experience through workshops and interactive activities
Gather inputs for Biological Evaluation Plan
Prepare Biological Evaluation Report
Understand how to maintain biocompatibility assessment documents
And more!
Who Should Take This Course?
It is recommended you have relatable experience prior to taking this course. This masterclass is designed to be interactive and practical, with a focus on hands-on learning. This course is for you if you’re looking for a mix of lectures, group discussions, case studies, and workshops, to ensure you have a comprehensive understanding of the principles of biocompatibility. We’ll provide participants with real-life examples and practical insights, to illustrate the application of biocompatibility principles in the medical device industry. Finally, Introduction to Biocompatibility will offer opportunities for participants to ask questions and receive feedback from the instructor and their peers, ensuring a collaborative and engaging learning experience.
Introduction to Biocompatibility
This 2-day masterclass will provide practical insights and tools needed to evaluate a medical device from a biocompatibility perspective and adhere to global standards for different geographies. You will learn about the history of biocompatibility, how to apply a risk-based approach to a biological evaluation, global submission requirements and common pitfalls.
The program is designed to be interactive and engaging, with plenty of opportunities for hands-on practice and workshops. By the end of the program, you will have a thorough understanding of the principles of biocompatibility and the ability to apply them to ensure the safety and efficacy of medical devices.
What You’ll Learn:
How to conduct a biocompatibility evaluation from a risk-based approach
Understand the key global standards related to biocompatibility testing, including ISO-10993
How to identify and fill gaps in the biocompatibility assessment process
Gain practical insights into global submission requirements for different geographies
Learn how to avoid common mistakes in biocompatibility evaluation and testing
Meet your instructor:
Marina Daineko, MSc
Marina Daineko is a seasoned Biocompatibility Consultant based in Europe, specializing in ISO 10993-1 – she is also our Director of Business Development & Biocompatibility Consultant here at Intrinsic Medical Group.
With extensive experience in the medical device industry, she adeptly develops biocompatibility assessment aligned with ISO 14971:2019 and Medical Device Regulation (EU MDR). Her expertise extends to ensuring compliance with regulatory requirements across various global markets.
Marina's contributions to the field include speaking at conferences and delivering online training courses on biological safety and evaluation. Her work not only enhances product safety but also supports successful regulatory submissions. Marina holds a MSc in Analytical Chemistry, was the recipient of the Women in Tech Award Nominee in 2023 and is the author of 15 white papers and 2 patents in Materials Science field.
Certification Course Testimonies
Events
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We are proud to attend conferences and events around the world that focus on medical device regulation, highlighting our commitment to advancing this critical field. These gatherings allow us to connect with industry leaders, share the latest research, and discuss best practices. Be sure to check back for updates on our upcoming events, as we look forward to collaborating and driving innovation with you!