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Quality & Environment

Quality you can document.

We help our customers meet the medico industry's requirements for quality, documentation and validation – in a structured and manageable way.

Standards we work to

Certified, validated and traceable.

01

ISO 9001:2015

Quality management in all assignments within our certified ISO 9001:2015 management system.

Certified management system

02

GxP & GAMP 5

We construct machines that meet the international guidelines within GxP and GAMP 5.

International guidelines

03

FMEA from the URS phase

Risks on the machine and the final product are analysed from the very start, in the URS phase.

Risk analysis · traceability

Quality

Trust is built into every machine.

Medical equipment must meet essential safety and performance regulations to satisfy all requirements from authorities, patients and users. If that trust is broken, it can lead to a sudden drop in sales of the product concerned.

At MME Nordic, we help our customers meet the requirements for quality, documentation and validation that the medico industry is subject to – in a structured and manageable way. We perform quality management in all assignments within our certified ISO 9001:2015 management system, and we construct machines that meet the international guidelines within GxP and GAMP 5.

GxP & GAMP 5

Guidelines we build by.

At MME Nordic, we work to the following guidelines within GxP and GAMP 5:

  • Establishment and implementation of an effective quality assurance system

  • Clearly defined manufacturing processes that are systematically reviewed

  • Documentation and validation in close dialogue with the customer

  • The necessary facilities: qualified and trained staff, suitable rooms, equipment, materials, containers and labels, approved documents and appropriate storage and transport

  • Instructions and regulations written in clear and unambiguous language

  • Training of staff to carry out procedures correctly

Risk analysis & traceability

Risks handled from day one.

As a manufacturer, it is important to know the possible risks on the machine as well as on the final product. We take these risks into account already in the URS phase, where we carry out a thorough FMEA analysis.

We ensure clear traceability in both the requirements and the implementation, documented in a separate, easy-to-follow document – so the requirements are easy to identify.

Environment & responsibility

Responsibility built into how we work.

We make conscious choices that promote a sustainable future – in our own processes and in the machines we build for our customers.

Climate-friendly power

We buy green power from NRGi, sourced exclusively from Danish wind turbines – contributing to reduced CO2 emissions.

Danish wind power

Health and well-being

Health insurance for all employees, and faster time-to-market for medical devices that improve quality of life for people with chronic conditions.

UN SDG 3

Industry, innovation & infrastructure

By automating production lines and making processes smarter, we help our customers minimise waste, improve quality and use less energy.

UN SDG 9

Responsible consumption & production

We save natural resources, recycle and sort waste, buy as few environmentally harmful products as possible, and encourage employees and suppliers to do the same.

UN SDG 12

Reports & policies

How we approach sustainable development.

As part of Eltronic Group, we refer to the Group's policies on Environment, Social and Governance (ESG).

External report · ESG

Eltronic Group Sustainability Report 2024/2025

Learn how MME Nordic, as part of Eltronic Group, approaches sustainable development.

Open report

Eltronic Group · Policies

ESG policies

Read the Group's policies on Environment, Social and Governance on Eltronic Group's website.

Read the policies

Let's talk

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