CE marking · Risk assessment
What hazards can your product present, to whom and in what situations? A well-conducted risk assessment answers these questions before a user discovers them. We identify your product’s risks across its whole life cycle, evaluate them and help you reduce them, using the method suited to your sector.
Who it is for
Moving parts, energy sources, safety functions, maintenance and foreseeable misuse.
Electric shock, fire, overheating, batteries, radiation.
Risk management throughout the life cycle, benefit and risk.
Physical hazards and cybersecurity threats, combined in a single analysis.
Our approach
A structured approach, carried out with your teams, from the product’s context of use through to the residual risks.
Intended use, reasonably foreseeable misuse, users, environment, life cycle phases from transport to dismantling: we set the framework before looking for risks.
What you receive
Electrical, mechanical, thermal, radiation, chemical, ergonomics, software: in workshops with your teams, we review every hazard and every hazardous situation, in operation, during maintenance and under fault conditions.
What you receive
For each risk, we estimate the severity and probability of harm, decide whether it is acceptable, and propose measures in this order: inherently safe design, safeguarding, then information for use.
What you receive
For a connected product, risks also come from attacks: we identify the assets, threats and attack scenarios, and assess the risks with a threat analysis (TARA).
What you receive
Why a risk assessment
A requirement of EU legislation, but above all a design tool.
Most legislation requires it in one form or another: machinery, low voltage, medical devices, toys, connected products.
E.g. Directive 2014/35/EU, Annex III; Directive 2009/48/EC, Article 18It justifies the design choices, the standards applied, the tests carried out and the warnings in the instructions. It is often the first document an auditor examines.
Carried out at the design stage, it avoids costly corrections after testing, and recalls after placing on the market.
Methods
These standards describe analysis methods. The choice depends on your product and the legislation that applies; we make it with you.
| Field | Standard | Scope |
|---|---|---|
| Machinery | EN ISO 12100:2010 | General principles for design, risk assessment and risk reduction |
| Medical | EN ISO 14971:2019/A11:2021 | Risk management for medical devices |
| Methods | IEC 31010* | Risk assessment techniques: FMEA, HAZOP, fault tree analysis… |
| Methods | IEC 60812* | Failure modes and effects analysis (FMEA) |
| Cyber | IEC 62443-3-2:2020 | Cybersecurity risk assessment for industrial systems |
| Cyber | ISO/SAE 21434* | Threat analysis and risk assessment (TARA), automotive sector |
| Cyber | ETSI TS 102 165-1* | Threat, vulnerability and risk analysis |
* Edition to be checked for your project. The method chosen and its justification are set out in the risk assessment report.
Our approach
Your product, its use and its stage of development. 30 minutes.
Drawings, schematics, prototype, field experience: we prepare the analysis.
Identification and evaluation of risks with your teams.
Risks, measures and residual risks, ready for your technical documentation.
Frequently asked questions
Does your product raise a specific question? Ask an engineer directly.
Book a callFor most products, yes. The Machinery Regulation requires a risk assessment, the Low Voltage Directive an analysis and assessment of the risks in the technical documentation, the Toy Safety Directive a safety assessment, and the Medical Devices Regulation a risk management system. The form varies, but the aim remains the same: to find and reduce the product’s risks.
Sources: Directive 2014/35/EU, Annex III; Directive 2009/48/EC, Article 18; Regulation (EU) 2017/745, Annex I
It depends on the product and the sector: EN ISO 12100 for machinery, ISO 14971 for medical devices, methods such as FMEA or HAZOP to analyse failures, and a threat analysis (TARA) for cybersecurity. We choose the appropriate method and scale it to the complexity of your product.
From the design stage, while choices are still easy to change, and then whenever the product evolves. An assessment done at the end, purely for the technical file, misses its main purpose: making the product safer.
A conventional risk assessment starts from the hazards the product may present to people or property. A threat analysis starts from the possible attacks on the product, its data and its interfaces. For a connected product, the two complement each other: an attack can create a hazardous situation.
The limits of the product and its intended use, the list of hazards and hazardous situations, the estimation and evaluation of each risk, the risk reduction measures adopted and the residual risks to be stated in the instructions. It fits straight into your technical documentation.
Book a call
Book a 30-minute slot with an engineer directly. No back-and-forth by email: you choose the time, we prepare the call.
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