ISO 10993
ISO 10993 is a set of standards that helps ensure medical devices are safe for use with patients. It's like a safety checklist that manufacturers must follow to prove their products won't harm people when used. This includes testing for things like allergic reactions, irritation, or other harmful effects. When someone mentions ISO 10993 on their resume, it means they understand how to make sure medical products meet these important safety requirements. Think of it as similar to food safety standards, but for medical devices like implants, surgical tools, or any device that touches or goes inside the human body.
Examples in Resumes
Led biocompatibility testing program following ISO 10993 guidelines for new surgical devices
Managed compliance documentation for ISO 10993 and ISO 10993-1 biological evaluation
Developed testing protocols in accordance with ISO 10993 standards for implantable devices
Typical job title: "Biocompatibility Specialists"
Also try searching for:
Where to Find Biocompatibility Specialists
Professional Organizations
Online Communities
Job Resources
Example Interview Questions
Senior Level Questions
Q: How would you develop a biocompatibility testing strategy for a new implantable device?
Expected Answer: A strong answer should explain how they would assess the device's patient contact duration and type, select appropriate tests based on risk assessment, and develop a testing timeline that aligns with product development goals while ensuring patient safety.
Q: How do you stay current with changes in ISO 10993 standards and how have you implemented updates in previous roles?
Expected Answer: Should demonstrate knowledge of how standards evolve, mention specific recent changes, and provide examples of successfully updating testing programs or documentation to meet new requirements.
Mid Level Questions
Q: What are the main categories of biocompatibility testing under ISO 10993?
Expected Answer: Should be able to explain the basic test categories like cytotoxicity, sensitization, and irritation in simple terms, and when each type of testing is required.
Q: How do you determine which parts of ISO 10993 apply to a specific medical device?
Expected Answer: Should explain how device classification, contact duration, and type of body contact influence which tests are needed, using straightforward examples.
Junior Level Questions
Q: What is the purpose of ISO 10993?
Expected Answer: Should explain that it's a standard for ensuring medical devices are safe for patient use through biological testing and evaluation.
Q: What documentation is typically required for ISO 10993 compliance?
Expected Answer: Should mention basic requirements like test reports, risk assessments, and material information needed to show compliance.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of biocompatibility testing
- Familiarity with test documentation
- Knowledge of medical device materials
- Understanding of basic safety requirements
Mid (2-5 years)
- Test protocol development
- Risk assessment preparation
- Vendor management for testing labs
- Technical report writing
Senior (5+ years)
- Testing strategy development
- Regulatory submission preparation
- Project management of testing programs
- Risk management expertise
Red Flags to Watch For
- No understanding of basic biocompatibility concepts
- Lack of experience with medical device regulations
- Unable to explain risk assessment processes
- No knowledge of documentation requirements
- Unfamiliarity with medical device quality systems
Related Terms
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