Certificates

Documenting effective processes

At Medidyne we continuously adjust the way we work and update our processes and procedures to meet ever-changing market demands and regulatory requirements. Getting certified helps us to do so: The certificates introduced below document that we conduct business according to well-defined, effective processes. These processes help us maintain a high quality throughout all activities in the company and work actively towards reducing our environmental footprint.

ISO 13485 certification

We put great emphasis on offering top quality solutions to our customers, as well as providing top quality service and support throughout all interactions with our company. The entire Nordic Medidyne organization is ISO 13485 certified. This certification documents that we have an effective system for managing quality in the company.

The ISO 13485 sets requirements for quality management systems in companies working with medical devices in one or more stages of the product life cycle from product design to service and support. The internationally agreed standard helps organizations to consistently meet customer and applicable regulatory requirements for safety and quality in the medical devices industry.

Medidyne A/S, Medidyne AB, Medidyne AS and Medidyne Oy have been certified according to EN ISO 13485:2016 by Bureau Veritas.

ISO 13485 Management System Certification by Bureau Veritas

ISO 14001 certification

We believe that every person and organization have a role to play and a responsibility to help mitigate global climate change. Therefore, we take action to minimize our environmental footprint. The entire Nordic Medidyne organization is ISO 14001 certified. This certification documents that we have an effective environmental management system in place.

The ISO 14001 is an internationally recognized standard for environmental management systems. It is applicable in all types of organizations. An ISO 14001 certificate helps organizations demonstrate that they are taking proactive measures to minimize their environmental footprint, comply with relevant legal requirements, and achieve environmental objectives.

Medidyne A/S, Medidyne AB, Medidyne AS and Medidyne Oy have been certified according to ISO 14001:2015 by Bureau Veritas.