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Design & Development consultation

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Guest user Created:   Feb 11, 2021 Last commented:   Feb 12, 2021

Design & Development consultation

I am *** from medical device (glove manufacturer) company. As the pic for the design & development , would like to get more understanding regarding design & development as per 1S0 13485 (also MDSAP if can). There are few question from me which hope you can advise:

1) We are OEM company, so one product will be sell to few customers.
a) the market region might be differ according to customers. So how should I put into the design input as it also covers the markets region. Example, the product is design to customer A for US market. After few years customer B would like to purchase the same product but for Australia market. Should we just revised the design input or need to remark into design changes? Need your comment.

2. Can you elaborate further for IS0 13485 clause 7.3.3 Design Inputs which stated " Requirement shall be complete, unambigous, able to be verified or validated, and not conflict to each other" ? How can we verify these ?

Looking forward to your reply. 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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Kristina Zvonar Brkić Feb 12, 2021
1) We are OEM company, so one product will be sell to few customers. a) the market region might be differ according to customers. So how should I put into the design input as it also covers the markets region. Example, the product is design to customer A for US market. After few years customer B would like to purchase the same product but for Australia market. Should we just revised the design input or need to remark into design changes? Need your comment.

Since this is a change in the input data the best way would be to put market change as a design change. Any change to an existing approved document is considered a change to the document. In Design and development process there are two types of changes: changes in design and changes in the process. A design change is an alteration of the device's design basis. The incentive for design change is often field or other quality problems. Process changes change process management methods, but are not intended to change design; however, a design change can force changes in the process. Your market change is a design change.

For more information, see:

2. Can you elaborate further for IS0 13485 clause 7.3.3 Design Inputs which stated " Requirement shall be complete, unambigous, able to be verified or validated, and not conflict to each other" ? How can we verify these ?

The main point here is to check are your design inputs written well enough. The key is to avoid being overly broad. Think narrowly instead. When you defined your inputs, think in advance are those inputs can be verified or validated, are there any tests that can prove those input data. So, for some input data there will be possible to verify, but some not. For example, the market data that you mentioned in the previous question can not be verified or validated. But, if as input data you defined some physical characteristics, then definitively you can have some tests with which you will prove it.

 

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Feb 11, 2021

Feb 12, 2021