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Medical Device Post-Market Surveillance Audit Checklist

A comprehensive checklist for auditing post-market surveillance processes in medical device companies, ensuring compliance with ISO 13485 standards and improving ongoing product safety and performance monitoring.

Medical Device Post-Market Surveillance Audit Checklist

by: audit-now
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About This Checklist

The Medical Device Post-Market Surveillance Audit Checklist is a vital tool for healthcare organizations to ensure ongoing compliance with ISO 13485 standards after product launch. This comprehensive checklist focuses on monitoring the safety and performance of medical devices in real-world settings, helping manufacturers identify and address potential issues promptly. By implementing robust post-market surveillance processes, companies can enhance patient safety, maintain regulatory compliance, and continuously improve their products. This checklist aids in systematically evaluating data collection methods, complaint handling procedures, and adverse event reporting, ultimately contributing to better healthcare outcomes and reduced risks associated with medical device use.

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Industry

Healthcare

Standard

ISO 13485 - Medical Device Quality Management

Workspaces

Medical Device Manufacturing Facilities

Occupations

Quality Assurance Specialist
Regulatory Affairs Manager
Clinical Affairs Specialist
Product Safety Officer
Post-Market Surveillance Coordinator
1
Is the complaint handling process compliant with ISO 13485 requirements?
2
What is the average response time to complaints (in days)?
Min: 0
Target: 5
Max: 30
3
Is the adverse event reporting compliant with ISO 13485 requirements?
4
What actions have been taken to improve the post-market surveillance process?
5
How frequently is post-market surveillance data analyzed?
6
What is the total number of complaints received in the last quarter?
Min: 0
Target: 50
Max: 1000
7
What were the findings from the latest root cause analysis of complaints?
8
Is the post-market surveillance process compliant with regulatory requirements?
9
Are post-market surveillance reports submitted within the required timelines?
10
What was the date of the last post-market surveillance report submission?
11
How many post-market surveillance reports have been filed in the last year?
Min: 0
Target: 12
Max: 100
12
What are the key findings from the recent post-market surveillance activities?
13
What is the identified risk level associated with the medical device?
14
How many risk mitigation actions have been implemented?
Min: 0
Target: 3
Max: 100
15
What actions have been taken to mitigate identified risks?
16
When was the last risk assessment conducted?
17
Is the training for post-market surveillance staff compliant with ISO 13485 requirements?
18
How many staff members have received training on post-market surveillance in the last year?
Min: 0
Target: 25
Max: 100
19
What feedback has been received regarding the effectiveness of the training provided?
20
When is the next scheduled training session for post-market surveillance staff?

FAQs

The checklist covers areas such as data collection methods, complaint handling procedures, adverse event reporting, trend analysis, corrective and preventive actions (CAPA), field safety corrective actions (FSCA), and periodic safety update reporting.

It includes items to verify the effectiveness of data collection and analysis processes, ensuring that potential safety signals are promptly identified, investigated, and addressed through appropriate actions.

The audit should involve cross-functional teams including quality assurance specialists, regulatory affairs professionals, clinical affairs personnel, and product managers to ensure comprehensive evaluation of post-market activities.

Post-market surveillance audits should be conducted at least annually, with more frequent reviews for high-risk devices or when significant safety concerns arise.

Inadequate post-market surveillance can lead to delayed identification of safety issues, increased risk to patients, regulatory sanctions, product recalls, and damage to the company's reputation in the healthcare industry.

Benefits of Medical Device Post-Market Surveillance Audit Checklist

Ensures compliance with ISO 13485 post-market surveillance requirements

Improves early detection of potential safety issues or product defects

Enhances customer satisfaction through prompt complaint resolution

Facilitates continuous product improvement based on real-world data

Reduces the risk of regulatory non-compliance and potential penalties