1
What is the next deadline for submitting a regulatory report? Select the date of the next reporting deadline.
To ensure awareness of upcoming reporting deadlines and maintain compliance. 2
Is there an active recall for the device? Select the recall status.
To determine if any devices are currently under recall, affecting patient safety. 3
How many devices are currently being monitored under post-market surveillance? Enter the total number of devices being monitored.
To understand the scope of devices that require ongoing monitoring. Min: 1
Target: 50
Max: 1000
4
Provide a summary of post-market surveillance activities conducted in the last quarter. Detail the post-market activities undertaken.
To document the activities and ensure continuous monitoring and improvement. 5
When was the last evaluation of recalls conducted? Select the date of the last recall evaluation.
To ensure that evaluations of recalls are performed timely and effectively. 6
Is the device monitoring process compliant with ISO 14971? Select compliance status.
To ensure compliance with safety and risk management standards. Compliant Non-Compliant Needs Attention Clear
7
What is the frequency of monitoring the medical device (in days)? Enter monitoring frequency in days.
To evaluate whether monitoring activities are performed regularly. 8
What is the risk assessment level of the monitored device? Select the risk assessment level.
To identify the risk level associated with the device. High Risk Moderate Risk Low Risk No Risk Clear
9
Are formal post-market surveillance procedures in place? Indicate whether formal procedures exist.
To ensure that there are documented processes for monitoring device performance. 10
Is the incident reporting process compliant with established protocols? Select compliance status.
To verify that incidents are reported according to regulatory and internal standards. Compliant Non-Compliant Clear
11
Please provide a summary of any incidents reported in the last quarter. Provide a brief summary of reported incidents.
To assess the nature and frequency of incidents related to device performance. 12
What is the average resolution time for incidents reported (in days)? Enter average resolution time in days.
To evaluate the efficiency of the incident resolution process. 13
Describe any corrective actions taken as a result of incidents. Detail the corrective actions implemented.
To document the effectiveness of corrective measures and continuous improvement. 14
Is the device performance evaluated against safety standards? Select the evaluation status.
To confirm that device performance is regularly assessed to ensure safety and efficacy. Compliant Non-Compliant Clear
15
How many performance evaluations have been conducted in the past year? Enter the total number of evaluations conducted.
To determine the frequency of performance evaluations and ensure they are conducted regularly. 16
When was the last performance evaluation conducted? Select the date of the last evaluation.
To track the recency of the last evaluation and ensure timely assessments. 17
What was the outcome of the last performance evaluation? Select the evaluation outcome.
To document the results and actions taken following the evaluation. Satisfactory Needs Improvement Unsatisfactory Clear
18
Is the regulatory reporting process compliant with local regulations? Select the compliance status.
To ensure adherence to regulatory requirements for reporting device performance and incidents. Always Sometimes Rarely Clear
19
What feedback have you received from users regarding the device? Provide details of user feedback.
To gather insights on user experiences and identify areas for improvement. 20
How many regulatory reports have been submitted in the past year? Enter the total number of regulatory reports submitted.
To assess the reporting activity and ensure timely submissions. 