ISO 10993-1:2025 — Biological Evaluation of Medical Devices Essentials Training by Tonex
Built for teams who must get biological safety right the first time, this course turns ISO 10993-1:2025 from dense text into clear, usable practice. Participants learn how to plan evaluations, justify testing, and present evidence that stands up to regulatory scrutiny. Connected devices and digital quality systems add new exposure points for data and documentation.
We highlight how secure data handling, identity control, and tamper-evident records protect the credibility of biological conclusions. Weak cybersecurity can corrupt study outputs, break traceability, and compromise patient safety. You will leave with a pragmatic roadmap that blends biological science, risk management, and trustworthy documentation.
Learning Objectives
- Understand the structure and scope of ISO 10993-1 2025 within a risk based approach
- Build biological evaluation plans that align with intended use and patient contact categories
- Select and justify proportional tests linked to endpoints and exposure duration
- Perform toxicological evaluations using weight of evidence and transparent assumptions
- Generate defensible documentation including a coherent Biological Evaluation Report
- Apply secure data handling so cybersecurity safeguards protect evaluation integrity
Audience
- Regulatory affairs specialists
- Quality and compliance managers
- R&D and design engineers
- Clinical and toxicology professionals
- Manufacturing and supplier quality leaders
- Cybersecurity Professionals
Course Modules
Module 1 — Standard Overview
- Define purpose and scope
- Clarify terms and references
- Map 10993 series links
- Explain risk based principles
- Identify 2025 updates
- Outline roles and inputs
Module 2 — Biological Risk Planning
- Profile intended use
- Classify patient contact
- Assign exposure duration
- Select evaluation endpoints
- Structure evaluation plan
- Set acceptance criteria
Module 3 — Material Characterization
- Build material inventory
- Profile chemical constituents
- Plan extractables studies
- Plan leachables studies
- Choose analytical methods
- Integrate supplier data
Module 4 — Toxicological Assessment
- Identify hazards and data
- Estimate exposure and TTC
- Interpret dose response
- Address uncertainty factors
- Synthesize weight of evidence
- Write tox conclusions
Module 5 — Test Strategy Design
- Choose in vitro or in vivo
- Cover cytotoxicity and sensitization
- Address irritation and systemic
- Assess hemocompatibility needs
- Evaluate degradation products
- Justify waivers and equivalence
Module 6 — Documentation and Review
- Compile BER structure
- Link traceability evidence
- Prepare audit readiness
- Manage change control
- Maintain data integrity
- Plan post market follow up
Strengthen your team’s command of ISO 10993-1:2025 and protect the credibility of your biological evidence. Enroll with Tonex to master risk planning, toxicology justification, and secure documentation practices that accelerate approvals while safeguarding patients.