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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?

Select compliance status.

To ensure adherence to regulatory standards and effective complaint management.
2
What is the average response time to complaints (in days)?

Enter the average response time in days.

To assess the efficiency of the complaint handling process.
Min: 0
Target: 5
Max: 30
3
Is the adverse event reporting compliant with ISO 13485 requirements?

Select compliance status.

To ensure that adverse events are reported in accordance with regulatory requirements.
4
What actions have been taken to improve the post-market surveillance process?

Describe the improvement actions taken.

To document continuous improvement efforts and ensure ongoing compliance.
5
How frequently is post-market surveillance data analyzed?

Select the frequency of data analysis.

To determine if the analysis is conducted regularly for timely identification of issues.
6
What is the total number of complaints received in the last quarter?

Enter the total number of complaints.

To monitor the volume of complaints and identify trends in product safety.
Min: 0
Target: 50
Max: 1000
7
What were the findings from the latest root cause analysis of complaints?

Provide details on the findings of the root cause analysis.

To evaluate the effectiveness of root cause analysis in addressing issues.
8
Is the post-market surveillance process compliant with regulatory requirements?

Select compliance status.

To ensure adherence to regulatory standards for product safety.
9
Are post-market surveillance reports submitted within the required timelines?

Select the timeliness status of report submissions.

To assess the efficiency of report submissions in compliance with regulatory timelines.
10
What was the date of the last post-market surveillance report submission?

Select the date of the last report submission.

To track compliance with reporting schedules and maintain records.
11
How many post-market surveillance reports have been filed in the last year?

Enter the total number of reports filed.

To quantify reporting activities and assess compliance with reporting requirements.
Min: 0
Target: 12
Max: 100
12
What are the key findings from the recent post-market surveillance activities?

Provide a summary of the key findings.

To evaluate important insights gained from surveillance activities.
13
What is the identified risk level associated with the medical device?

Select the identified risk level.

To categorize the risk associated with the device based on post-market surveillance findings.
14
How many risk mitigation actions have been implemented?

Enter the total number of risk mitigation actions.

To track the effectiveness of risk management strategies in response to identified risks.
Min: 0
Target: 3
Max: 100
15
What actions have been taken to mitigate identified risks?

Describe the risk mitigation actions taken.

To document specific actions implemented to address risks associated with the device.
16
When was the last risk assessment conducted?

Select the date when the last risk assessment was conducted.

To ensure timely evaluations of risks associated with the medical device.
17
Is the training for post-market surveillance staff compliant with ISO 13485 requirements?

Select the training compliance status.

To ensure that personnel are adequately trained to handle post-market surveillance activities.
18
How many staff members have received training on post-market surveillance in the last year?

Enter the total number of staff trained.

To assess the extent of training provided to personnel involved in post-market activities.
Min: 0
Target: 25
Max: 100
19
What feedback has been received regarding the effectiveness of the training provided?

Provide feedback received from participants about the training.

To evaluate the impact of training on staff capability in post-market surveillance tasks.
20
When is the next scheduled training session for post-market surveillance staff?

Select the date for the next training session.

To ensure continuous training and updates for personnel involved in post-market activities.

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