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Medical Device Risk Management Planning Checklist

This checklist is designed to assist in the development and implementation of risk management plans for medical devices, ensuring compliance with ISO 14971 standards and enhancing device safety.

Medical Device Risk Management Planning Checklist
by: audit-now
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About This Checklist

The Medical Device Risk Management Planning Checklist is a crucial tool for healthcare organizations committed to ISO 14971 compliance. This checklist assists in the development and implementation of comprehensive risk management plans for medical devices, ensuring that all potential risks are systematically identified and addressed. By utilizing this checklist, healthcare providers can enhance device safety, ensure regulatory compliance, and streamline risk management processes. Keywords: risk management planning, ISO 14971 compliance, medical device safety, healthcare risk strategy.

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Industry

Healthcare

Standard

ISO 14971

Workspaces

Hospital
Medical Device Manufacturing Facility
Healthcare Clinic

Occupations

Risk Manager
Medical Device Engineer
Quality Assurance Specialist
Compliance Officer
Healthcare Administrator

Risk Management Planning Audit

(0 / 4)

1
How effective are the current risk mitigation measures?

Select the effectiveness level.

To evaluate the effectiveness of implemented risk mitigation strategies.
2
How many risks have been identified in the current risk management cycle?

Enter the total number of identified risks.

To assess the thoroughness of the risk identification process.
Min: 0
Target: 0
Max: 100
3
Is there a documented risk management plan available?

Please provide details of the document.

To verify the existence of a formalized plan for managing risks associated with medical devices.
4
Is the risk management process compliant with ISO 14971?

Select the compliance status.

To ensure that the organization adheres to necessary international standards for risk management.
5
What is the highest severity level of identified risks (1-5)?

Enter the highest severity level (1 being the lowest and 5 being the highest).

To categorize the potential impact of identified risks and prioritize them accordingly.
Min: 1
Target: 1
Max: 5
6
What categories of risks have been identified?

Select all applicable risk categories.

To ensure a comprehensive understanding of the types of risks present.
7
When was the last risk assessment conducted?

Select the date of the last assessment.

To ensure that risk assessments are performed regularly and are up to date.
8
Who is part of the risk assessment team?

Please list the names and roles of team members.

To identify the personnel involved in the risk assessment process and their qualifications.
9
How effective is the post-market surveillance for the medical device?

Select the effectiveness level.

To assess the effectiveness of monitoring the device's performance after it has been released to the market.
10
How many safety incidents have been reported in the past year?

Enter the total number of safety incidents reported.

To evaluate the safety record of the medical device and identify trends.
Min: 0
Target: 0
Max: 100
11
Is there a documented process for reporting safety incidents?

Please provide details of the incident reporting process.

To ensure that there is a clear protocol for documenting and addressing safety incidents.
12
Is the medical device compliant with safety regulations?

Select the compliance status.

To confirm that the medical device meets safety standards set by regulatory bodies.
13
How would you rate the effectiveness of the current risk management process?

Select your rating of the risk management process.

To gather feedback on the perceived effectiveness of the risk management strategies in place.
14
Is there documentation for the current risk mitigation strategies?

Please provide details of the documentation.

To confirm that there are formalized strategies in place to mitigate identified risks.
15
How often are risk assessments reviewed?

Enter the frequency of reviews (e.g., annually, quarterly).

To determine whether risk assessments are conducted at appropriate intervals.
Min: 1
Target: Annually
Max: 12
16
Have all staff received training in risk management procedures?

Select the training status of the staff.

To ensure that all personnel are properly trained in risk management to mitigate potential risks.
17
How effective is the communication regarding patient safety among staff?

Select the effectiveness level of communication.

To evaluate the communication practices related to patient safety within the healthcare team.
18
How many adverse events have been reported in the past year?

Enter the total number of reported adverse events.

To assess the frequency of adverse events and identify areas needing improvement.
Min: 0
Target: 0
Max: 100
19
When was the last review of the patient safety protocols conducted?

Select the date of the last review.

To ensure that safety protocols are regularly reviewed and updated as necessary.
20
Are there established protocols for ensuring patient safety?

Please describe the patient safety protocols.

To verify that protocols are in place to protect patient safety during medical procedures.

FAQs

The purpose is to guide the development and implementation of risk management plans for medical devices.

Healthcare professionals involved in risk management planning and strategy should use this checklist.

It ensures that risk management plans align with ISO 14971 standards, supporting regulatory compliance.

Benefits include enhanced device safety, systematic risk identification, and improved risk management efficiency.

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

Benefits

Facilitates the development of comprehensive risk management plans.

Ensures compliance with ISO 14971 standards.

Enhances safety and reliability of medical devices.

Supports systematic identification and mitigation of risks.

Improves efficiency and effectiveness of risk management processes.