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Validation and Verification of Design and Development

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Guest user Created:   Oct 04, 2018 Last commented:   Oct 09, 2018

Validation and Verification of Design and Development

Our company manufactures 1st risk class medical devices. For the moment we are improving our QMS in accordance with requirements of the new version of the standard. Especially we are wondering what should be considered as validation and verification of design and development. For example, we want to modify our existing device due to a request from a doctor or just add in our range of products something similar from competitors. Please give some examples of documents for this. Thanks!
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Verlene Law Oct 04, 2018

Answer:

Validation of design and development means to ensure that that improvement made to the existing device will not affect the safety and performance of the intended use of the original device. Simply to say, the process/ improvement must be reproducible to yield a consistent result. Example of such a document could be a validation plan or validation protocol. Verification of design and development would mean that the steps taken to achieve the improvement are followed strictly in order to produce the same medical device as per intended. Example of such a document could be a checklist of specifications totally against the initial design and the actual design prototype.

For examples of a document, you may refer to the following materials:

Design and Development Verification and Validation Plans, https://advisera.com/13485academy/documentation/design-and-development-verification-and-validation-plans-iso-13485-2016/
Validation Report, https://advisera.com/13485academy/documentation/validation-report-iso-13485-2016/
Verification Report https://advisera.com/13485academy/documentation/verification-report-iso-13485-2016/

For more information about validation and verification of design and development, see these articles:

Using ISO 13485 to manage process validation in the medical device manufacturing industry - https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/
How to manage design and development of medical devices according to ISO 13485:2016 - https://advisera.com/13485academy/blog/2017/08/24/how-to-manage-design-and-development-of-medical-devices-according-to-iso-134852016/
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jjpei Oct 09, 2018
Hi, need advise on DHF. previously, the company is not ISO 13485 certified. but there are design activites that was done.. now that we need the DHF, but the documents /records are not available. What is the best way to deal with it? Can we open a CAPA and document that DHF not available and create a DHF for the product now? But how do we document the dates for the DHF> ? Etc the design plan, input for the activities will be way before date...please advise.
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Verlene Law Oct 11, 2018
Hi there, thank you for your question.

There is not a need to open a CAPA since the company is not complying to the standard previously. The Design File for the product can now be created as a brand new document with the templates.

For more information about the design file, you can refer to :
How to manage design and development of medical devices according to ISO 13485:2016
https://advisera.com/13485academy/blog/2017/08/24/how-to-manage-design-and-development-of-medical-devices-according-to-iso-134852016/
Design and Development File:
https://advisera.com/13485academy/documentation/design-and-development-file-iso-13485-2016/
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jjpei Oct 11, 2018
Hi, but the design for the product is not new, and already in market. the design validation, verification etc can be documented with brand new document templates?
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Verlene Law Oct 11, 2018
The previous provided answer is still applicable in your case.
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