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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?
2
How effective is the post-market surveillance process?
3
What is the total number of reported incidents in the last year?
Min: 0
Target: 0
Max: 1000
4
Have corrective actions been implemented for identified issues?
5
What is the risk assessment status of the reported incidents?
6
When was the last review of the post-market surveillance process conducted?
7
Is there comprehensive documentation for all risk management activities?
8
How effective are the implemented risk control measures?
9
How many training sessions on risk management have been conducted this year?
Min: 0
Target: 5
Max: 50
10
Are risk assessments updated regularly?
11
When is the next scheduled review of the risk management process?
12
How compliant is the organization with relevant regulatory requirements?
13
What method is used for collecting user feedback on medical devices?
14
Have user suggestions been implemented in product improvements?
15
How many user feedback entries have been received in the last year?
Min: 0
Target: 150
Max: 1000
16
What is the severity level of reported issues based on user feedback?
17
When was the last review of user feedback conducted?
18
What challenges have been encountered in collecting user feedback?
19
Is there a current risk management plan in place for the medical devices?
20
How many risks have been identified during the last risk assessment?
Min: 0
Target: 20
Max: 100
21
How effective are the risk mitigation strategies implemented?
22
What recent changes have been made to the risk management process?
23
When was the last review of the risk management plan conducted?
24
Has staff received training on the risk management process in the last year?
25
What types of post-market surveillance activities are being conducted?
26
Is user feedback integrated into the product development process?
27
How many safety reports have been generated in the past year?
Min: 0
Target: 30
Max: 200
28
When was the post-market surveillance plan last updated?
29
How often are safety review meetings held to discuss post-market surveillance findings?
30
What challenges have been faced in conducting post-market surveillance?

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 of ISO 14971 Post-Production Risk Monitoring Checklist

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