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 20M - 20M
Notice Type:
Contract Notice
Published Date:
22 September 2025
Closing Date:
06 October 2025
Location(s):
SE213 Kalmar län (SE Sweden/SVERIGE)
Description:
An integrated system is needed to support the eHealth Agency's compliance with EU and national regulations regarding medical devices and to achieve certification for its quality management system.

This procurement concerns an integrated system support to ensure the eHealth Agency's compliance with requirements in the EU Regulation on Medical Devices (EU 2017/745) as well as HSLF-FS 2022:42 (national regulations on NMI), and that we effectively and systematically meet regulatory requirements and stakeholders' 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 eHealth Agency's compliance with requirements in the EU Regulation on Medical Devices (EU 2017/745) as well as HSLF-FS 2022:42 (national regulations on NMI), and that we effectively and systematically meet regulatory requirements and stakeholders' 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:
Additional document: 1
Link:
Download Full Notice as PDF
Link:
View Full Notice
CPV Code(s):
48000000 - Software package and information systems
72000000 - IT services: consulting, software development, Internet and support