Training Features

Biological Safety Evaluation of Medical Devices

Gain the knowledge and tools to successfully plan and execute biological safety evaluations that ensure compliance and market approval.
Format

Virtual Training

Level

Basis

Date

17 November 2026

Time

14:00 - 17:00 CET

Duration

3 hours

Trainer

Patrícia da Silva Perez

Certificate

Certificate included

Price

€ 395 or equivalent currency

Training on Biological Safety and Biocompatibility for Medical Devices

Biological safety is a critical aspect of medical device development, ensuring that materials and devices are safe for human use. Compliance with ISO 10993-1 and regulatory requirements under the EU MDR 2017/745, IVDR 2017/746, and US FDA guidance is essential for market approval. 

Led by Patrícia da Silva Perez, this interactive training provides an in-depth overview of biological safety evaluation, covering biocompatibility testing, risk assessment, material selection, and regulatory expectations. Participants will gain practical insights into planning and executing biological evaluations in line with global standards.

Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
Biological safety is fundamental in medical device development, ensuring that all materials and devices are safe for human use and compliant with global regulatory requirements. This training provides participants with a clear understanding of ISO 10993-1, the EU MDR 2017/745, IVDR 2017/746, and FDA expectations for biocompatibility testing and biological evaluation. 

The training covers risk assessment, material characterization, testing strategies, toxicological evaluations, and how to integrate findings into Biological Evaluation Plans (BEPs) and Reports (BERs). Through practical insights, case studies, and regulatory perspectives, participants will learn how to design and document biological evaluations that meet the requirements of regulators worldwide. Upon completion, participants will receive a certificate confirming their knowledge of biological safety and compliance practices.
Key Learning Objectives
  • Understand the regulatory requirements for biological safety evaluation under ISO 10993-1, MDR, IVDR, and FDA. 
  • Learn how to conduct a risk-based biological evaluation of medical devices. 
  • Identify appropriate biocompatibility tests for different device categories. 
  • Gain insights into chemical characterization and toxicological risk assessment. 
  • Develop and document a compliant Biological Evaluation Plan and Report. 
  • Learn how to integrate biological safety into the overall risk management process. 
  • Understand post-market surveillance requirements for biological safety.
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered in one session, lasting 3 hours in total, providing a focused and efficient learning experience. The sessions will take place on 17 November 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If this training date is not suitable, additional sessions will be held on 16 June 2026. More information can be found on the registration pages.
Who Should Attend?
  • Regulatory Affairs professionals responsible for biocompatibility compliance. 
  • Quality Assurance managers ensuring biological safety in QMS processes. 
  • R&D teams involved in material selection and product development. 
  • Toxicologists and biocompatibility specialists in the medical device industry. 
  • Testing laboratory professionals conducting biocompatibility evaluations. 
  • Risk management professionals assessing biological hazards.
  • Professionals preparing MDR, IVDR, or FDA submissions requiring biocompatibility data.
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Regulatory Framework for Biological Safety: Covers ISO 10993-1, its role in biological evaluation, EU MDR, IVDR, FDA requirements, and the risk-based approach to biological safety compliance. 
  • Biological Risk Assessment and Material Characterization: Focuses on identifying biological risks, chemical characterization, extractables/leachables testing, and integration with ISO 14971 principles. 
  • Biocompatibility Testing Strategies: Explains in vitro and in vivo approaches, key tests such as cytotoxicity, sensitization, irritation, systemic toxicity, and selecting appropriate methods by device classification and use. 
  • Toxicological Risk Assessment and Justification: Covers evaluating toxicological data, threshold-based and alternative strategies, and using literature and historical data to reduce animal testing. 
  • Implementation in the Biological Evaluation Plan (BEP) and Report (BER): Guides the development of structured BEPs, documentation of biological safety evaluations, and meeting Notified Body and FDA submission expectations. 
  • Challenges in Biological Safety Compliance: Highlights common pitfalls in testing and submissions, managing supplier or device changes, and adapting to evolving regulatory expectations. 
  • Challenges in Biological Safety Compliance: Highlights common pitfalls in testing and submissions, managing supplier or device changes, and adapting to evolving regulatory expectations. 

Flexible Online Training Designed for MedTech Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with practical industry experience and gain clear, actionable insights into navigating x.

Expert-Led Training for Practical Compliance

Meet the Trainer

Patrícia da Silva Perez

Patrícia da Silva Perez, PhD, is an expert in biocompatibility, clinical evaluations, and regulatory affairs, with over five years of experience in the medical device industry, particularly in the dental field, and she is now part of Qserve's Clinical Operations unit.