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Difference between 3.10 Release in production/ market and 3.12 Transfer to production

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Guest user Created:   Jan 08, 2021 Last commented:   Jan 26, 2021

Difference between 3.10 Release in production/ market and 3.12 Transfer to production

Can you please clarify the difference between 3.10 Release in production/ market and 3.12 Transfer to production?

Is this relevant for Software as medical device also?

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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.

Expert
Kristina Zvonar Brkić Jan 11, 2021

Requirement 3.10 Release in production means that after all the design processes that you have performed, now you will make one final product as a prototype. This prototype must be verified before releasing to the market to determine whether the product complies with all requests defined in the Project Task. 

Design and development transfer must:

Establish and maintain procedures to ensure that the device design—its components and configuration—is correctly translated into production specifications.Transfer the product design into production methods and procedures.Create a production environment that ensures the product complies with regulatory requirements and industry standards.This is mostly applicable when there is a massive production, so you can state that this is not applicable to you.  

For more information on design and development, please see the following articles:

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Guest user Jan 25, 2021

Thanks, Kristina,

Two questions regarding Document and record control:

Is 3.7.2 and 3.7.4 related to health records only or general demands exemplified by health records or?

3.7.2. Managing of changes
[Job title] must ensure that all changes in records are clear and traceable.
If clinical study records are kept as part of the medical device validation, [Job title] must ensure the protection of confidential health records in accordance with applicable regulations.

3.7.4. Record protection, availability and retrieval
If health records are kept as part of the medical device production or service provision, [Job title] must ensure the protection of health records’ confidentiality in accordance with applicable regulations.
Employees of the organization may access stored records only after obtaining permission from the person designated as the person responsible for storing individual records. If the sensitivity of certain records is such that permission for access must be obtained from a different person, this must be stated in the concerned internal document in the chapter describing records control.
Access and retrieval rights for records are determined by the owner of individual records. [Job title] is responsible for destroying all records of which the retention time has expired.
If the records are stored on computer they must be backed up at least [describe the usual practice in organization].
[Job title] must ensure the records are retained for the lifetime of the medical device, as specified by organization or applicable regulatory requirements, with a retention period of at least two years from the device release by the organization. 

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Kristina Zvonar Brkić Jan 26, 2021

This is related to the general demands exemplified by health records.

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Jan 08, 2021

Jan 26, 2021