In the medical sector, regulation is not an accessory layer applied at the end of a project. It is a structural element that shapes how devices are conceived, developed and brought to market.
Talking about medical certification therefore means talking about method. It means operating within highly regulated processes, where every technical decision must be supported by evidence, analysis and structured documentation. In this context, engineering work takes on a form that differs significantly from many other industrial domains.
Design, prototyping and testing remain essential, but they represent only part of the overall effort. A substantial portion of the work is dedicated to a less visible activity: building a solid, coherent and standards-compliant documentation system that accompanies the product throughout its lifecycle.
Designing means proving
In medical technology, expectations are clear: high reliability and minimal risk.
Achieving these objectives is not simply a matter of making a device work. It requires demonstrating that every potential risk has been identified, analysed and mitigated according to precise regulatory criteria. Reliability is not assumed. It is proven.
Risk analysis therefore extends beyond the product itself. It encompasses the entire project, including processes, manufacturing steps and organisational choices. Methodologies such as FMEA and FMECA are applied not only to device functions, but also to the way systems are built, assembled and produced.
From FMEA to FMECA: structuring risk awareness
FMEA (Failure Modes and Effects Analysis) is a preventive methodology designed to identify possible failure modes in a system, component or process and to evaluate their effects. Its purpose is to anticipate problems before they occur, analysing how failures may impact system operation or user safety and defining corrective actions to reduce risk.
FMECA (Failure Modes, Effects and Criticality Analysis) extends this approach by introducing a quantitative assessment of criticality. Originally formalised by the MIL-STD-1629 standard, FMECA makes it possible not only to identify failures, but also to prioritise interventions based on their potential impact on the system.
Over time, this distinction has led to two complementary approaches: FMEA, focused on identifying failures and their effects, and FMECA, which adds a layer of criticality assessment. This distinction reflects an important reality: risk does not arise only from design choices. It can also emerge during assembly, material handling or production repeatability.
For this reason, high reliability is required not only from those who design medical devices, but also from those who manufacture them. Robustness must be embedded in every part of the system.
Standards, documentation and quality systems
Operating in the medical sector means working within a structured regulatory framework made up of technical standards, procedures and detailed documentation requirements. Compliance is not achieved through a single final test. It is the result of a structured path that accompanies the entire development lifecycle.
Within this framework, a quality system certified according to ISO 13485 plays a central role. It is not simply a formal requirement, but an organisational structure that enables consistent management of processes, responsibilities and traceability.
Through ISO 13485-certified processes and procedures, Eletech, Head of the International Design Centres, R&D division of the Group supports the development of medical devices from the earliest project phases, ensuring that regulatory requirements are addressed systematically and coherently throughout development.
Medical technology and other regulated sectors
Medical regulation is complex and significantly more articulated than that of many traditional industrial fields. However, it does not represent the most stringent regulatory environment in absolute terms.
In sectors such as railway and aerospace, functional safety requirements impose even stricter constraints. In these contexts, certification does not only assess the final product. It enters the design domain from the very beginning. Certification bodies may evaluate the project concept itself, requiring engineering teams to justify architectural choices and design rationales before development is allowed to proceed.
This level of scrutiny is not typically required in the medical sector. Nevertheless, compared to most industrial applications, medical technology still demands an exceptionally high level of discipline, documentation and control. While it may be considered “lighter” than railway applications in terms of formal functional safety, it remains far more demanding than many other industries.
Cross-sector experience as a source of value
Experience across sectors with different regulatory intensities allows these differences to be interpreted with greater awareness. A global view of regulatory contexts makes it possible to adapt methods and procedures to each specific domain, applying a structured and well-informed engineering approach.
Thanks to this cross-sector competence, developed in particularly demanding environments such as railway, aerospace and medical, Eletech approaches medical projects with a method centred on risk prevention, process robustness and overall system quality.
In the medical field, certification is not merely a mandatory step. It is the outcome of a way of designing in which reliability is not a final objective, but a starting condition.
Meeting the medical ecosystem
As a global leader in mechatronics for a wide range of high-tech industries, including advanced Medical and Healthcare, Elemaster Group will take part in one of the sector’s most prestigious international events.
From 9 February 2026, the Group will be present at World Health Expo in Dubai, with its international team available in Hall North 21, Booth F113, to share its approach to medical technology, grounded in quality, certification and engineering excellence.