Shelf Life Studies
Shelf Life Studies are detailed investigations that determine how long medical devices can safely remain usable when stored. These tests help companies prove their products will work correctly and safely throughout their stated storage period. Think of it like checking how long food stays good in your refrigerator, but for medical devices, it's much more rigorous and scientific. Companies need these studies to get approval from regulators like the FDA and to make sure their products are safe for patients. When you see this term in resumes, it usually means the person has experience in product testing, quality control, or regulatory compliance.
Examples in Resumes
Managed Shelf Life Studies for Class II medical devices ensuring FDA compliance
Led team conducting accelerated Shelf Life Studies and stability testing
Developed protocols for Shelf Life Testing of sterile medical products
Coordinated Shelf Life Analysis and stability testing programs across multiple product lines
Typical job title: "Medical Device Quality Engineers"
Also try searching for:
Where to Find Medical Device Quality Engineers
Professional Organizations
Online Resources
Job Boards
Example Interview Questions
Senior Level Questions
Q: How would you design a shelf life study program for a new medical device product line?
Expected Answer: Look for answers that discuss creating comprehensive testing plans, understanding regulatory requirements, risk assessment, considering various environmental factors, and managing multiple studies simultaneously. They should mention documentation requirements and how to handle any issues that arise.
Q: How do you determine appropriate sample sizes for shelf life studies?
Expected Answer: Should explain how to balance statistical significance with practical constraints like cost and time, while meeting regulatory requirements. Should mention consideration of product variability and risk levels.
Mid Level Questions
Q: What factors do you consider when setting up storage conditions for shelf life testing?
Expected Answer: Should mention temperature, humidity, light exposure, packaging integrity, and how these relate to real-world storage conditions. Should understand accelerated aging concepts.
Q: How do you handle out-of-specification results in a shelf life study?
Expected Answer: Should discuss investigation procedures, documentation requirements, impact assessment, and corrective actions. Should mention the importance of communication with stakeholders.
Junior Level Questions
Q: What is the purpose of accelerated aging testing?
Expected Answer: Should explain that accelerated aging uses higher temperatures to simulate longer storage times, allowing faster results while maintaining product safety standards.
Q: What basic documentation is required for shelf life studies?
Expected Answer: Should mention test protocols, data collection forms, environmental monitoring records, and final reports. Should understand the importance of accurate record-keeping.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of testing procedures
- Data collection and documentation
- Following established protocols
- Basic quality control concepts
Mid (2-5 years)
- Protocol development
- Data analysis and interpretation
- Understanding of regulatory requirements
- Project coordination
Senior (5+ years)
- Program development and oversight
- Risk assessment and management
- Regulatory strategy development
- Team leadership and training
Red Flags to Watch For
- No knowledge of FDA or regulatory requirements
- Lack of experience with documentation practices
- Unable to explain basic testing concepts
- No understanding of quality control principles
- No experience with data analysis or interpretation
Related Terms
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