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Filling documents

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Guest user Created:   Jun 21, 2023 Last commented:   Jun 26, 2023

Filling documents

1. On the risk management matrix, should we include departments such as finance and administration that are not quite an essential part of the process to make and develop our product?

2. On the 9th document "Design and Developempent" there says we should include record of old versions of the designs of the product, but our question is how much records should we include? Should we include since our first design (which is from 2021) or could we just include the designs from a year ago to now? Or is there a minimum record time that must be met?

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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 Jun 26, 2023

1. On the risk management matrix, should we include departments such as finance and administration that are not quite an essential part of the process to make and develop our product?

Considering the risk management according to ISO 14971:2019 particularly for medical device manufacturers, only risks related to the medical product and which may affect the safety of the product must be covered. This means that finance and administration departments usually are not covered with risk management for medical devices. 

2. On the 9th document "Design and Developempent" there says we should include record of old versions of the designs of the product, but our question is how much records should we include? Should we include since our first design (which is from 2021) or could we just include the designs from a year ago to now? Or is there a minimum record time that must be met?

You need to include records from your first design and keep those records for at least 10 years after the last device is sold on the market for all classes except for class III and class IIB implantable which is necessary to keep for 15 years.

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Jun 21, 2023

Jun 26, 2023

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