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Design Control Process Audit Checklist for Medical Devices

A comprehensive checklist for auditing the design control process in medical device development, ensuring compliance with ISO 13485 standards and improving overall product quality and safety.

Design Control Process Audit Checklist for Medical Devices

by: audit-now
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About This Checklist

The Design Control Process Audit Checklist for Medical Devices is a crucial tool for ensuring compliance with ISO 13485 standards in the healthcare industry. This checklist focuses on the design and development aspects of medical devices, helping organizations maintain rigorous control over their product development lifecycle. By systematically evaluating design inputs, outputs, verification, validation, and transfer processes, companies can minimize risks, enhance product quality, and meet regulatory requirements. Implementing this checklist can lead to improved patient safety, reduced time-to-market, and increased confidence in the final medical device product.

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Industry

Healthcare

Standard

ISO 13485 - Medical Device Quality Management

Workspaces

Medical Device Research and Development Facility

Occupations

Design Engineer
Quality Assurance Specialist
Regulatory Affairs Manager
Project Manager
Medical Device Developer
1
Is the design verification process compliant with ISO 13485 standards?
2
What is the average time taken to analyze design change requests (in days)?
Min: 0
Target: 30
Max: 60
3
Describe the methods used for design validation.
4
How effective is the risk management process in identifying potential design risks?
5
Is the design documentation complete and up to date?
6
How frequently are design reviews conducted (in months)?
Min: 1
Target: 6
Max: 12
7
List the training records related to design control for team members.
8
Have all design changes been approved by authorized personnel?
9
Are the design input requirements verified against the initial specifications?
10
Provide feedback from the most recent design review.
11
What is the impact assessment score for the last design change (1-10)?
Min: 1
Target: 5
Max: 10
12
When was the last design validation conducted?
13
Do the design outputs meet the specified requirements?
14
What issues were identified during the design validation process?
15
How many design changes have been recorded in the last year?
Min: 0
Target: 10
Max: 100
16
What actions have been taken following the design validation?
17
Has a design risk assessment been completed for the project?
18
How many risk mitigation plans have been developed for identified design risks?
Min: 0
Target: 3
Max: 20
19
Provide a summary of the risks identified during the design phase.
20
When is the next review scheduled for the design risks?

FAQs

This checklist covers design planning, design inputs, design outputs, design review, design verification, design validation, design transfer, design changes, and design history file maintenance.

The checklist ensures that risk management activities are integrated throughout the design process, helping identify and mitigate potential risks associated with the medical device early in the development cycle.

The audit process should involve cross-functional teams including design engineers, quality assurance specialists, regulatory affairs professionals, and project managers to ensure comprehensive evaluation of the design control process.

Design control audits should be conducted at key milestones throughout the product development process, as well as annually to ensure ongoing compliance and continuous improvement.

Failure to follow proper design control processes can lead to product defects, regulatory non-compliance, delayed market approval, costly recalls, and potential harm to patients.

Benefits of Design Control Process Audit Checklist for Medical Devices

Ensures compliance with ISO 13485 design control requirements

Reduces risks associated with medical device design flaws

Improves traceability throughout the product development lifecycle

Facilitates efficient design transfer to manufacturing

Enhances overall product quality and patient safety