Risk Assessment Services
While the rigorous application of standards such as ISO 12100 and ISO 14971 is often viewed simply as a legal requirement for CE marking, we believe hazard analysis is a universal product safety imperative rather than just a regional hurdle.
- ISO 12100:2010ISO 12100Safety of machinery, risk assessment and risk reduction
- ISO 14971:2019ISO 14971Risk management for medical devices
- 2006/42/ECMachinery Directive Annex IEssential health and safety requirements
Risk Assessment, explained.
While the rigorous application of standards such as ISO 12100 and ISO 14971 is often viewed simply as a legal requirement for CE marking, we believe hazard analysis is a universal product safety imperative rather than just a regional hurdle. Our comprehensive risk assessments satisfy not only European Union Directives but also the UK Supply of Machinery Safety Regulations and United States OSHA and ANSI standards, such as ANSI B11.0. We apply rigorous global hazard identification principles to ensure your product safety profile is thoroughly defensible worldwide. We recognise that comprehensive risk assessments are the evidence-led foundation of product safety. Internal design teams can naturally develop blind spots regarding their own innovations, which is why objective, expert oversight is crucial. Working seamlessly as an integrated extension of your engineering team, we deliver clear, honest advice and peer-reviewed mitigation strategies. Our collaborative approach actively reduces your regulatory and physical risk while meticulously maintaining your core product functionality and design intent.
How we deliver this service
A structured sequence runs behind every project so nothing is missed and the deadline stays in sight from day one.
Technical Correctness
Our risk assessments satisfy not only EU Directives but also the UK Supply of Machinery (Safety) Regulations and US OSHA/ANSI standards (such as ANSI B11.0). We apply global hazard identification principles to ensure your safety profile is defensible worldwide.
AMS Values
Risk assessments are the evidence-led foundation of product safety. Working as an integrated extension of your engineering team, we deliver clear, honest advice and peer-reviewed mitigation strategies that actively reduce risk while maintaining product functionality.
The directives and standards we work with
Each recommendation ties back to a specific directive, annex, or harmonised standard.
| Regulation | Number | Scope |
|---|---|---|
| ISO 12100 | ISO 12100:2010 | Safety of machinery, risk assessment and risk reduction |
| ISO 14971 | ISO 14971:2019 | Risk management for medical devices |
| Machinery Directive Annex I | 2006/42/EC | Essential health and safety requirements |
| General Product Safety Regulation | (EU) 2023/988 | Risk assessment for consumer products |
Often delivered together
These services are commonly scoped as part of a single engagement.
Get a realistic timeline for your risk assessment project
In this 20-minute call, you will receive a list of applicable directives, likely testing needs, and clear next steps.