How do you validate and verify the effectiveness and safety of design changes?

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Design changes are inevitable in the medical device industry, as new technologies, customer feedback, regulatory requirements, and quality issues may prompt modifications to the device design specifications. However, any change can introduce new risks or affect the device's performance, safety, or effectiveness. Therefore, you need to validate and verify the design changes before implementing them in the production process. In this article, you will learn how to apply the principles of design control to manage design changes and ensure their compliance and suitability.

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Adarsh S Kothari

Medical Devices | Project Management (PMP)? | Verification & Validation | Test Management | Six Sigma Quality (GB)? |…

1 What are design validation and verification?

Design validation and verification are two essential activities in the design control process that ensure that the device meets the user needs and the design inputs. Design validation is the process of confirming that the device conforms to the defined user needs and intended uses, while design verification is the process of confirming that the device meets the specified design inputs. Both validation and verification require objective evidence, such as test results, data analysis, simulations, inspections, or reviews, to demonstrate that the design outputs meet the acceptance criteria.

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Adarsh S Kothari

Medical Devices | Project Management (PMP)? | Verification & Validation | Test Management | Six Sigma Quality (GB)? | Quality Management
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1.For major/significant change, impacting the intended use, PRD, compliance, sw architecture, safety features, critical component, labels, regulations etc., Draft a V&V plan for design change scope and tests to be performed. 2.Verification of the change, impacted subsystems along with regression to be thoroughly tested. Risk analysis and use error has to be checked and updated in risk file. Compliance, usability, reliability and clinical tests has to be factored if the change demands. 3.Validation of the change, use error validation, risk mitigation, safety feature and software validation in the intended environment to be carried out. 4.Perform the effectiveness check, document the results and review with stakeholders before formal release.

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Ghanshyam Maheshwari
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As a road designer, ensuring design verification and safety are seamlessly integrated is crucial. Both are essential: design verification adheres to standard engineering protocols, while safety focuses on a human-centric approach to protect and enhance user experience. First, review the design specifications to ensure they meet standards and regulations. Next, check the design in models for performance and safety, and calculate the life cycle cost .Compile the findings into a detailed report, considering the overall project cost and timeline, and have it reviewed by a multidisciplinary team. Finally, implement the changes in a controlled environment and monitor their performance before construction begins.

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2 When to perform design validation and verification for changes?

According to the FDA guidance on design control, you should perform design validation and verification for any design change that could affect the device's safety or effectiveness. However, the extent and type of validation and verification may vary depending on the nature and impact of the change. For example, a minor change that does not alter the device's intended use or performance may require only a limited verification, while a major change that introduces a new function or feature may require a full validation and verification. You should document the rationale and justification for the level of validation and verification required for each design change.

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Offir Shenfeld

Design Quality Assurance Manager @ GE Healthcare | Certified QMS Lead Auditor
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Every design change is the product lifecycle is assessed by the required functions to identify the impacted areas, and applicable design control activities to secure the change is safe, effective, and meets the required modification. At the early stages of the change control, once impacted areas are identified, the Design Control team member will work with the relevant key functions to define a plan and planned deliverables to be completed before the design change can be released and implemented in the production line.

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3 How to plan design validation and verification for changes?

The first step in planning design validation and verification for changes is to identify and document the design inputs that are affected by the change. Design inputs are the requirements and specifications that define the device's characteristics, functions, performance, safety, and quality. You should review the design inputs and determine how the change will modify or impact them. You should also ensure that the design inputs are clear, complete, consistent, and testable.

The next step is to define and document the design outputs that are relevant to the change. Design outputs are the results of the design activities that describe the device's physical and functional characteristics. You should identify and document the design outputs that correspond to the affected design inputs and reflect the change. You should also ensure that the design outputs are measurable, traceable, and compliant with the applicable standards and regulations.

The final step is to establish and document the acceptance criteria and methods for validation and verification. Acceptance criteria are the standards or benchmarks that determine whether the design outputs meet the design inputs. Methods are the procedures or techniques that generate the objective evidence for validation and verification. You should define and document the acceptance criteria and methods for each design output that is relevant to the change. You should also ensure that the acceptance criteria and methods are appropriate, reliable, and consistent with the device's user needs and intended uses.

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Janak Das

Leader | Proactive | Achiever | Communicator | Creative
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In industries like Medical Device, modifications to Design Inputs driven by design changes would happen in the very early phases of development, if the user need/voice of customer was not fully realized in the form of design inputs. A rule of thumb is to ensure the design meets the specification rather than update the specification to meet the design.

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4 How to conduct design validation and verification for changes?

The next step is to conduct design validation and verification for changes according to the plan. You should perform the validation and verification methods on the design outputs and collect the objective evidence. You should also document the results and compare them with the acceptance criteria. You should evaluate whether the design outputs meet the design inputs and whether the device conforms to the user needs and intended uses. You should also identify and document any deviations, discrepancies, or nonconformities that may occur during the validation and verification process.

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5 How to document design validation and verification for changes?

The final step is to document design validation and verification for changes in a clear and comprehensive manner. To do this, you should create and maintain a design history file (DHF) that contains all the records and documents related to the validation and verification process. This should include the design inputs and outputs that are affected by the change, the rationale and justification for the level of validation and verification required, the acceptance criteria and methods, objective evidence and results of validation and verification, evaluation and conclusion of validation and verification, any deviations, discrepancies, or nonconformities that occurred, as well as corrective and preventive actions (CAPA) taken to address them. Ultimately, this DHF should demonstrate that the design change was validated and verified in a systematic and rigorous manner to ensure it meets user needs and intended uses.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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How do you validate and verify the effectiveness and safety of design changes?

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1 What are design validation and verification?

2 When to perform design validation and verification for changes?

3 How to plan design validation and verification for changes?

4 How to conduct design validation and verification for changes?

5 How to document design validation and verification for changes?

6 Here’s what else to consider

Design Control

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