Verification and Validation in Medical Devices
Do you need to verify and validate your medical device in order to certify it? Do you need help with regression testing to recertify your medical device?
At SQS, we are experts in verification and validation activities in regulated environments. We have over 20 years of experience in this field.
V&V Software as a Medical Device
We help you with the verification and validation tasks for your MDSW in accordance with IEC 82304-1 and IEC 62304 standards.
V&V Medical Equipment
With extensive experience in testing and validating equipment in accordance with IEC 62304 and the IEC 60601 series.
V&V Medical Device with AI
We help you verify and validate your AI medical device in accordance with the current regulatory framework.
Computer Systems Validation
We validate the computer systems used in critical processes for the development and manufacture of your medical device.
Contact an expert
If you would like to know more about this topic or have any other questions, please do not hesitate to contact us.
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ISO 9001:2015
ISO 14001:2015
UNE-ISO/IEC 20000-1:2018
ISO/IEC 27001:2013
UNE-EN ISO/IEC 17025:2017
ENS-nivel medio
Approved IDS Evaluation Facility
ISO 9001
ISO/IEC 27001
ENS-nivel medio
ISO 20000
UNE-EN ISO/IEC 17025
Approved IDS Evaluation Facility
ISO 14001
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