The key changes and what they mean for manufacturers
ISO 10993-1 has been comprehensively revised with noticeable effects on risk analysis, chemical characterization, clinical data and biocompatibility strategy. In this compact eLearning, you will learn what has changed, why it is important and what your company needs to do now. The training was specially developed to quickly give you confidence in dealing with the new expectations of the standard – standard-compliant, practical and audit-proof.
With modules and practical examples, you will learn how to efficiently align your documentation and decision-making processes with the new requirements.
Why should you choose our eLearning course?
- The latest know-how on ISO 10993-1
You will receive an update that is precisely tailored to the innovations of the 2025 version of the standard, including interpretation, industry trends and typical pitfalls for manufacturers. - Focus on practical implementation
The content comes from real project situations and advises you specifically on the following questions- What needs to be adjusted?
- Which tests are now required more often?
- What is no longer considered sufficient justification?
- Work through the training at your own pace – with checklists, decision trees, case studies and quizzes that deepen your understanding.
- Certificate included
Upon completion, you will receive a certificate confirming your qualification to the current ISO 10993-1 requirements.
- Content
- What’s new?
- Overview of the most important changes
- New structure & terminology: What is changing in concrete terms
- Extended requirements for biological risk analyses (approximation to ISO 14971
- Chemical characterization: new triggers & obligations
- Clinical data as part of biocompatibility
- Material Changes & Lifecycle Requirements
- New Decision Logic & Updated Test Requirements
- What has been facilitated?
- Savings potential & reductions
- What needs to be done with regard to existing products?
- Concrete to-dos for manufacturers
- Final examination and certificate
- What’s new?
- How you benefit
- You can immediately see which changes affect you and how to implement them correctly.
- You know when additional tests are necessary, which justifications are no longer sufficient and how to document trigger points correctly.
- You will learn how risk files, technical documentation and PMCF references must be revised in accordance with standards.
- Methods
- Concise trainer inputs
- Interactive elements, examples & decision trees
- Practical checklists & do/don’ts
- Quizzes
- Target Audience
- Regulatory Affairs
- Quality Management
- Development & Project Teams
- Clinical Affairs / PMCF
- Persons who prepare or are responsible for biocompatibility assessments
- Teams that need to migrate their documentation to the new standard version
