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Do we need sales procedure?

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Guest user Created:   Jul 13, 2022 Last commented:   Jul 15, 2022

Do we need sales procedure?

We are not yet at a stage where we know who our ‘customer’ will be. Meaning that we are designing and developing our medical devices, and are funded through shareholder investment and grants. Our plan will most likely be to license out our technology and have another company be responsible for the manufacturing of the implant aspect. Therefore, from reading the clause about sales I do not think we need a process at the moment? Our stage 1 and stage 2 audits are later this year, and nothing will change in terms of our readiness stage. Our scope is purely for the design and development of medical devices. So in this case, we do not need a sales procedure – correct?
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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 Jul 15, 2022

No matter that you for now do not have classic sales, giving the license to another company and having some communication with them is part of the sales process. The sales process is not just sales of the final product to the final users, but rather all communication that you have with the companies that use your service. 
Therefore, you need the sales procedure, but it will be specific for you for the communication with the licensed company. 

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Jul 13, 2022

Jul 15, 2022

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