Program Overview
This 1-day intensive program provides a deep dive into biocompatibility requirements for medical devices, combining ISO 10993 standards, EU MDR expectations, and risk-based approaches. Delivered by an expert with 25+ years of experience, the workshop blends conceptual grounding, regulatory situational awareness, case-based learning, and practical simulations. Participants will learn how to plan biological evaluations, address testing and documentation gaps, apply risk-based justification, and align with EU MDR compliance. With actionable exercises and real-world insights, this program equips professionals to handle corporate-level biocompatibility challenges with confidence.
Features
- Understand the ISO 10993 framework and EU MDR requirements for biocompatibility
- Apply risk-based biological safety evaluations in device development
- Identify and resolve compliance gaps in testing, documentation, and reporting
- Build a corporate-ready roadmap for biological evaluation planning and execution
Target audiences
- Regulatory Affairs Professionals
- Quality Assurance Professionals
- R&D Professionals
- Product Development Teams
- Compliance Officers
Curriculum
- 4 Sections
- 17 Lessons
- 1 Day
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- Introduction to Biocompatibility & ISO 109934
- 1.1Definition and scope of biocompatibility in medical devices
- 1.2Overview of ISO 10993 standards (focus on parts relevant to corporates: biological evaluation, toxicology, risk assessment)
- 1.3EU MDR expectations for biocompatibility documentation
- 1.4Key concepts: Cytotoxicity, Sensitization, Genotoxicity, Toxicokinetics, Endpoints, Chemical Characterization, Biological Risk Assessment
- Risk-Based Approaches & Compliance Challenges5
- 2.1Applying risk-based evaluation in line with ISO 14971 & MDR
- 2.2Material selection vs. biological safety requirements
- 2.3Challenges corporates face: Incomplete chemical characterization, Legacy devices and MDR transition, Limited availability of testing data
- 2.4EU MDR requirements for biological evaluation reports (BERs)
- 2.5Key concepts: Gap Analysis, Justification of Non-Testing, Biological Safety Strategy, Master File Approach
- Lessons from Industry Practice4
- 3.1Case Study 1: Successful MDR submission with risk-based biological evaluation
- 3.2Case Study 2: Rejection due to inadequate ISO 10993 testing & documentation gaps
- 3.3Case Study 3: Leveraging literature & historical data to avoid redundant testing
- 3.4Expert-guided discussions: “What went wrong? How would you mitigate it?”
- Practical Application of Biocompatibility Framework4
- 4.1Exercise 1: Drafting a biological evaluation plan for a hypothetical device
- 4.2Exercise 2: Reviewing a case dossier – spotting gaps in chemical characterization & test justification
- 4.3Group Exercise: Creating a risk-based roadmap for device biocompatibility compliance
- 4.4Expert debrief & action recommendations
Instructor
