Quality Certifications Across Dream Devices
Dream Devices brings together two expert organisations under one brand: Dream Devices Technologies and Dream Devices Mechanics. Together, we offer end-to-end product development services across embedded systems, electronics, software, and mechanical design. Both companies operate under certified quality management systems, which form a solid foundation for our work in regulated industries.
Dream Devices Mechanics holds certifications under ISO 9001, the globally recognized quality management system standard, and ISO 13485, the harmonized QMS standard for the medical device industry. These certifications support consistent quality, process control, and regulatory compliance in product development for both industrial and medical sectors. Dream Devices Technologies, on the other hand, is certified under ISO 9001 and IEC 62304, ensuring compliance in both hardware and medical software development.
These certifications demonstrate our shared commitment to quality, reliability, and regulatory compliance across disciplines.
External Audit Completed Without Non-Conformities
In March 2025, Dream Devices Technologies Oy completed a scheduled external quality audit conducted by Bureau Veritas. This was a recertification audit, part of the three-year audit cycle. The first full certification was achieved in 2022 and has since been followed by annual surveillance audits.
The latest audit focused on two key standards: ISO 9001:2015 and IEC 62304:2006 + Amd1:2015. Both areas were found to be fully compliant, with no non-conformities or observations raised. This outcome affirms the robustness and maturity of our quality management system.
Quality at the Core of Our Operations
ISO 9001 is a globally recognized framework for quality management. It promotes continuous improvement, operational efficiency, and customer satisfaction through a process-oriented and risk-based approach. The audit covered core business areas including leadership, sales, and procurement, verifying that our practices align with the standard’s key principles.
Ensuring Safe and Compliant Medical Software
IEC 62304 outlines the lifecycle requirements for medical device software, covering planning, development, testing, maintenance, and risk management. At Dream Devices Technologies, we apply this standard rigorously in our medical projects to ensure product safety and regulatory compliance. The audit also included software and hardware engineering as well as lab processes, all of which met the required criteria.
In addition to the audited standards, our day-to-day development work regularly involves compliance with other critical regulations in the medical and laboratory device domain. On the hardware and mechanical side, we are experienced in working according to IEC 60601-1 and IEC 61010-1, which define essential safety and performance requirements for medical and laboratory equipment. We also apply IEC 60601-1-2, which governs electromagnetic compatibility (EMC) for medical devices.
While these standards were not directly covered in this audit, they remain a key part of our core competencies and practical know-how. This experience ensures we are well-equipped to support customers developing regulated products from concept to compliance.
