Post-Market Surveillance
Post-Market Surveillance is a system companies use to monitor the safety and performance of medical devices after they've been released to the market. Think of it like customer service meets safety monitoring - it's about keeping track of how devices perform in real-world use. Companies must do this to comply with regulations and ensure patient safety. This process involves collecting feedback from users, tracking any problems or complaints, and making improvements when needed. It's similar to how car manufacturers monitor their vehicles after sale, but for medical equipment.
Examples in Resumes
Led Post-Market Surveillance activities for Class III medical devices across European markets
Developed and implemented Post-Market Surveillance procedures compliant with MDR requirements
Managed Post Market Surveillance data collection and analysis for company's orthopedic product line
Coordinated PMS activities between quality assurance and regulatory affairs departments
Typical job title: "Post-Market Surveillance Specialists"
Also try searching for:
Where to Find Post-Market Surveillance Specialists
Professional Organizations
Job Boards
Professional Networks
Example Interview Questions
Senior Level Questions
Q: How would you set up a post-market surveillance system for a new medical device?
Expected Answer: Should explain process of creating data collection systems, setting up complaint handling procedures, establishing reporting channels with healthcare providers, and ensuring compliance with regulations like MDR or FDA requirements.
Q: How do you handle a situation where post-market data suggests a potential safety issue?
Expected Answer: Should discuss risk assessment procedures, decision-making process for corrective actions, communication with regulatory authorities, and when to consider field safety notices or recalls.
Mid Level Questions
Q: What types of data should be collected in a post-market surveillance program?
Expected Answer: Should mention customer complaints, clinical data, user feedback, repair reports, and adverse events. Should understand how to organize and analyze this information.
Q: How do you ensure compliance with post-market surveillance regulations?
Expected Answer: Should discuss knowledge of current regulations, documentation requirements, periodic safety update reports, and maintaining quality system procedures.
Junior Level Questions
Q: What is the purpose of post-market surveillance?
Expected Answer: Should explain basic concept of monitoring device safety and performance after market release, identifying potential issues, and ensuring patient safety.
Q: What are the basic components of a complaint handling system?
Expected Answer: Should describe process of receiving, documenting, and investigating complaints, and basic understanding of when to escalate issues.
Experience Level Indicators
Junior (0-2 years)
- Basic complaint handling
- Data collection and entry
- Understanding of medical device regulations
- Basic quality system documentation
Mid (2-5 years)
- Complaint investigation and analysis
- Report writing and trending
- Risk assessment
- Regulatory reporting requirements
Senior (5+ years)
- Program development and management
- Risk management strategies
- Team leadership
- Regulatory authority interaction
Red Flags to Watch For
- No knowledge of basic medical device regulations
- Lack of experience with quality management systems
- Poor understanding of risk assessment
- No experience with complaint handling or investigation
Related Terms
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