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ISO 14971 Post-Production Risk Monitoring Checklist

A specialized checklist designed to guide the post-production risk monitoring process for medical devices, ensuring ongoing compliance with ISO 14971 standards and facilitating continuous improvement in product safety and performance.

ISO 14971 Post-Production Risk Monitoring Checklist

by: audit-now
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About This Checklist

The ISO 14971 Post-Production Risk Monitoring Checklist is a crucial tool for healthcare organizations and medical device manufacturers to ensure ongoing compliance with risk management standards after product release. This checklist focuses on the critical phase of post-market surveillance, helping to identify and address emerging risks, adverse events, and opportunities for product improvement. By implementing this checklist, companies can maintain vigilance over their products' safety and performance, respond promptly to new information, and continuously enhance patient safety. The structured approach provided by this checklist aids in meeting regulatory requirements and maintaining the integrity of risk management systems throughout the product lifecycle.

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Industry

Healthcare

Standard

ISO 14971 - Medical Device Risk Management

Workspaces

Medical Device Manufacturing Facilities

Occupations

Quality Assurance Specialist
Regulatory Affairs Manager
Post-Market Surveillance Coordinator
Clinical Affairs Specialist
Product Safety Engineer
1
Is there a documented process for reporting adverse events?

Please provide details about the reporting process.

To ensure compliance with regulatory requirements for adverse event reporting.
2
How effective is the post-market surveillance process?

Select the effectiveness level.

To evaluate the effectiveness of ongoing monitoring of medical devices in the market.
3
What is the total number of reported incidents in the last year?

Enter the total number of incidents.

To assess the safety performance of the medical devices.
Min: 0
Target: 0
Max: 1000
4
Have corrective actions been implemented for identified issues?

Indicate if corrective actions have been taken.

To ensure that issues are being addressed and resolved effectively.
5
What is the risk assessment status of the reported incidents?

Select the risk assessment status.

To prioritize follow-up actions based on risk levels.
6
When was the last review of the post-market surveillance process conducted?

Select the date of the last review.

To ensure regular reviews are conducted for continuous improvement.
7
Is there comprehensive documentation for all risk management activities?

Please describe the documentation process.

To ensure compliance with ISO 14971 and proper traceability of risk management efforts.
8
How effective are the implemented risk control measures?

Select the effectiveness level.

To assess whether risk control measures are functioning as intended.
9
How many training sessions on risk management have been conducted this year?

Enter the number of training sessions.

To ensure staff are adequately trained in risk management practices.
Min: 0
Target: 5
Max: 50
10
Are risk assessments updated regularly?

Indicate if updates are performed regularly.

To verify that risk assessments reflect the current state of the product and market.
11
When is the next scheduled review of the risk management process?

Select the date of the next scheduled review.

To ensure that regular reviews are planned and executed.
12
How compliant is the organization with relevant regulatory requirements?

Select the compliance status.

To assess the organization's adherence to regulatory standards.
13
What method is used for collecting user feedback on medical devices?

Select the feedback collection method.

To ensure that there is a systematic approach for gathering user feedback for continuous improvement.
14
Have user suggestions been implemented in product improvements?

Indicate if user suggestions have been implemented.

To verify that user feedback is taken into account for product enhancements.
15
How many user feedback entries have been received in the last year?

Enter the total number of feedback entries.

To assess the volume of user engagement and feedback.
Min: 0
Target: 150
Max: 1000
16
What is the severity level of reported issues based on user feedback?

Select the severity level.

To categorize issues for prioritizing resolution efforts.
17
When was the last review of user feedback conducted?

Select the date of the last review.

To ensure that user feedback is reviewed regularly for potential improvements.
18
What challenges have been encountered in collecting user feedback?

Please describe any challenges faced.

To identify barriers to effective user feedback collection for future improvements.
19
Is there a current risk management plan in place for the medical devices?

Indicate if a risk management plan exists.

To ensure that a proactive approach to risk management is established.
20
How many risks have been identified during the last risk assessment?

Enter the total number of identified risks.

To gauge the thoroughness of the risk assessment process.
Min: 0
Target: 20
Max: 100
21
How effective are the risk mitigation strategies implemented?

Select the effectiveness rating.

To determine if the measures taken are successful in controlling identified risks.
22
What recent changes have been made to the risk management process?

Please describe any recent changes.

To keep track of improvements and adaptations in the risk management approach.
23
When was the last review of the risk management plan conducted?

Select the date of the last review.

To ensure that the risk management plan is reviewed periodically for updates.
24
Has staff received training on the risk management process in the last year?

Select the training status.

To confirm that staff is adequately trained to handle risks effectively.
25
What types of post-market surveillance activities are being conducted?

Select the types of activities conducted.

To ensure a variety of monitoring methods are employed for comprehensive safety evaluations.
26
Is user feedback integrated into the product development process?

Indicate if user feedback is integrated.

To verify that user insights are utilized for enhancing product features and safety.
27
How many safety reports have been generated in the past year?

Enter the total number of safety reports.

To track the volume of safety evaluations conducted within the reporting period.
Min: 0
Target: 30
Max: 200
28
When was the post-market surveillance plan last updated?

Select the date of the last update.

To ensure that the surveillance plan is current and reflects the latest regulatory requirements.
29
How often are safety review meetings held to discuss post-market surveillance findings?

Select the frequency of meetings.

To determine the regularity of discussions regarding safety outcomes and improvements.
30
What challenges have been faced in conducting post-market surveillance?

Please describe any challenges encountered.

To identify barriers that may hinder effective monitoring and reporting.

FAQs

The main focus is on monitoring and managing risks associated with medical devices after they have been released to the market, ensuring ongoing compliance with ISO 14971 standards.

The process should involve quality assurance teams, regulatory affairs specialists, product engineers, customer service representatives, and clinical affairs personnel.

Post-production risk monitoring should be an ongoing process, with formal reviews conducted at least quarterly, and immediate assessments performed when significant new information or events occur.

Data sources include customer complaints, adverse event reports, post-market clinical follow-up studies, scientific literature, and feedback from healthcare professionals and users.

By systematically collecting and analyzing post-market data, the checklist helps identify trends, potential design improvements, and opportunities to enhance product safety and effectiveness.

Benefits

Ensures continuous risk management and compliance with ISO 14971 post-market

Facilitates early detection of emerging risks and adverse events

Improves product safety and performance through ongoing monitoring

Supports timely implementation of corrective and preventive actions

Enhances communication between manufacturers, users, and regulatory bodies