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Medical Device Post-Market Surveillance Checklist

This checklist is designed to assist in the post-market surveillance of medical devices, ensuring compliance with ISO 14971 standards and enhancing device safety.

Medical Device Post-Market Surveillance Checklist

by: audit-now
4.3

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About This Checklist

The Medical Device Post-Market Surveillance Checklist is a vital tool for healthcare organizations focused on maintaining ISO 14971 compliance. This checklist aids in the systematic monitoring and evaluation of medical devices after they have been released to the market, ensuring that any emerging risks are promptly identified and managed. By utilizing this checklist, healthcare providers can enhance device safety, ensure ongoing regulatory compliance, and protect patient health. Keywords: post-market surveillance, ISO 14971 compliance, medical device monitoring, healthcare risk management.

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Industry

Healthcare

Standard

ISO 14971 - Medical Device Risk Management

Workspaces

Hospitals
Healthcare Centers
Medical Device Manufacturing Facilities

Occupations

Risk Manager
Post-Market Surveillance Specialist
Compliance Officer
Quality Assurance Specialist
Healthcare Safety Officer
1
What is the next deadline for submitting a regulatory report?
2
Is there an active recall for the device?
3
How many devices are currently being monitored under post-market surveillance?
Min: 1
Target: 50
Max: 1000
4
Provide a summary of post-market surveillance activities conducted in the last quarter.
5
When was the last evaluation of recalls conducted?
6
Is the device monitoring process compliant with ISO 14971?
7
What is the frequency of monitoring the medical device (in days)?
Min: 1
Target: 30
Max: 365
8
What is the risk assessment level of the monitored device?
9
Are formal post-market surveillance procedures in place?
10
Is the incident reporting process compliant with established protocols?
11
Please provide a summary of any incidents reported in the last quarter.
12
What is the average resolution time for incidents reported (in days)?
Min: 1
Target: 10
Max: 60
13
Describe any corrective actions taken as a result of incidents.
14
Is the device performance evaluated against safety standards?
15
How many performance evaluations have been conducted in the past year?
Min: 0
Target: 5
Max: 100
16
When was the last performance evaluation conducted?
17
What was the outcome of the last performance evaluation?
18
Is the regulatory reporting process compliant with local regulations?
19
What feedback have you received from users regarding the device?
20
How many regulatory reports have been submitted in the past year?
Min: 0
Target: 3
Max: 50

FAQs

This checklist can be applied in hospitals, medical device manufacturing facilities, and healthcare monitoring centers.

The purpose is to guide the monitoring and evaluation of medical devices after market release.

Healthcare professionals involved in post-market surveillance and risk management should use this checklist.

It ensures that emerging risks are promptly identified and managed, supporting proactive risk management.

Benefits include enhanced device safety, ongoing regulatory compliance, and improved patient safety.

Benefits of Medical Device Post-Market Surveillance Checklist

Facilitates systematic monitoring of medical devices post-market.

Ensures ongoing compliance with ISO 14971 standards.

Enhances safety and reliability of medical devices.

Supports proactive identification and management of emerging risks.

Improves patient safety through continuous device evaluation.