Integrated Management System for Quality and Information Security and Document Management | Tenderlake

Integrated Management System for Quality and Information Security and Document Management

Contract Value:
SEK 6M - 6M
Notice Type:
Contract Notice
Published Date:
26 September 2025
Closing Date:
06 October 2025
Location(s):
SE213 Kalmar län (SE Sweden/SVERIGE)
Description:
An integrated system is needed to support the Swedish eHealth Agency in complying with EU and national regulations for medical devices while ensuring certification against quality and information security standards.

This procurement concerns an integrated system support to ensure the Swedish eHealth Agency's compliance with the requirements of the EU regulation on medical devices (EU 2017/745) as well as HSLF-FS 2022:42 (national regulations on NMI) and that we efficiently and systematically fulfill regulatory requirements and stakeholder demands in accordance with SS-EN ISO 13485:2016 and SS-EN ISO/IEC 27001:2023. The goal is for the quality management system to obtain certification against these standards.


LOT-0001
urn:eavrop:mdn:ProcurementProject:116667:Lot:1
Integrated management system for quality and information security and document management.
This procurement concerns an integrated system support to ensure the Swedish eHealth Agency's compliance with the requirements of the EU regulation on medical devices (EU 2017/745) as well as HSLF-FS 2022:42 (national regulations on NMI) and that we efficiently and systematically fulfill regulatory requirements and stakeholder demands in accordance with SS-EN ISO 13485:2016 and SS-EN ISO/IEC 27001:2023. The goal is for the quality management system to obtain certification against these standards.

The Buyer:
E-hälsomyndigheten
Additional information:
Link:
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Additional document: 1
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CPV Code(s):
48000000 - Software package and information systems
72000000 - IT services: consulting, software development, Internet and support