Quality and Safety Management in Medical Devices
Do you need to implement a quality or safety management system in your company to meet regulatory requirements for marketing your product?
At SQS, we have extensive experience implementing both quality management systems and safety management systems.
ISO 13485 implementation
We support you in implementing a quality management system tailored to your company’s needs.
IEC 62304 implementation
We help define the regulatory strategy to follow and accompany you throughout the certification process.
ENS Implementation and Audit
We offer a service for implementing the ENS national security scheme.
ISO 27001 implementation and audit
We offer an ISO 27001 implementation service.
Implementation and Audit of IEC 81001-5-1
We help implement the cybersecurity lifecycle for your medical devices.
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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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