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Design and development and requirements of 7.1

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Guest user Created:   Dec 31, 2019 Last commented:   Jan 04, 2020

Design and development and requirements of 7.1

I'm establishing the QMS according to ISO 13485, I have been thinking about the change control, have to define the change control of design and development and other changes occurring during production days. Another question, how do you understand the requirements of 7.1? How to put them into practice?
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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 Jan 04, 2020

I'm sorry, but I do not understand your first question - could you please elaborate?

Considering requirement 7.1 Planning of product realization, you need to plan and to develop the processes that you need to realize products. It means that you need to make procedures, forms and any other kind of document that will prove that your product is produced in a certain way. Also, you need to develop a risk management process for product realization. It means that you need to analyze your manufacturing process from the point of view of product safety for the patient. So, what can happen during production, which can cause the product to come out unsafe. For risk guidance, please look for ISO 14971:2012. 

You also need to plan how you're going to realize your product, what raw materials you need, what equipment, what kind of premises and other infrastructure. You need to formulate what are quality objectives for your product, clarify specific product realization requirements, generate product realization planning outputs.

For more details about how to implement prodcution nad service provision, please read an article Production and service provision process in ISO 13485 on the following link: https://advisera.com/13485academy/blog/2017/12/13/production-and-service-provision-process-in-iso-13485/

Also you can read and article How to use ISO 14971 to manage risks for medical devices on the following link: https://advisera.com/13485academy/blog/2017/09/21/how-to-use-iso-14971-to-manage-risks-for-medical-devices/ 

 

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Dec 31, 2019

Jan 04, 2020