SHAREPOINT and ISO 13485:2016 Compliance

Our company uses Sharepoint for the online storage of files and information for our medical device company.  Could SHAREPOINT provide us with documentation to validate the following:

Safety and security of data stored on SHAREPOINT

Validation that data is not altered once it is uploaded to SHAREPOINT.  This would include MicroSoft Word and Excel tables

Any certification that can support using Sharepoint for the online storage of information on a Class II medical device.

Would appreciate your response.

Answer
Answer

Hi Stephen,

Thanks for your patience.

According to this link, Office 365 is verified to meet the requirements specified in ISO 27001, European Union (EU) Model Clauses, the Health Insurance Portability and Accountability Act Business Associate Agreement (HIPAA BAA), and the Federal Information Security Management Act (FISMA). For more information about whether it meets ISO 13485:2016, please click the small window in the left of the above link to get expert support about compliance certifications for Office 365.

Appreciate your understanding.

Regards,

Zixuan

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Last updated May 16, 2024 Views 2,894 Applies to: