Global Technical Documentation & File Compilation
Beyond the standard EU Technical Construction File, we compile comprehensive UKCA Technical Files under UK Statutory Instruments, as well as US FDA Design History Files and Device Master Records.
- 2006/42/ECMachinery Directive Annex VIITechnical file for machinery
- 2014/35/EULow Voltage Directive Annex IIITechnical documentation for electrical equipment
- 2014/30/EUEMC Directive Annex IITechnical documentation for EMC
Global Technical Documentation, explained.
Beyond the standard EU Technical Construction File, we compile comprehensive UKCA Technical Files under UK Statutory Instruments, as well as US FDA Design History Files and Device Master Records. Navigating these disparate international frameworks can easily overwhelm internal engineering teams. By harmonising these complex requirements, we build a single, robust documentation architecture tailored specifically for seamless multi-market entry. Compiling these intricate files requires deep, focused expertise. Our rigorous, peer-reviewed compilation process translates dense global regulations into clear, actionable engineering steps. We take ownership of the administrative burden, establishing a unified system that optimises your entire documentation structure. This strategic approach is meticulously designed to reduce your compliance risk, eliminate redundant paperwork, and accelerate your safe market access across the European Union, the United Kingdom, and the globe.
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
Beyond the EU Technical Construction File, we compile UKCA Technical Files under UK Statutory Instruments, as well as US FDA Design History Files (DHF) and Device Master Records (DMR). By harmonising these requirements, we build a single, robust documentation architecture for multi-market entry.
AMS Values
Our peer-reviewed compilation process translates dense regulations into clear, actionable engineering steps. We optimise your documentation structure to reduce risk and accelerate safe market access across the EU, UK, and the globe.
The directives and standards we work with
Each recommendation ties back to a specific directive, annex, or harmonised standard.
| Regulation | Number | Scope |
|---|---|---|
| Machinery Directive Annex VII | 2006/42/EC | Technical file for machinery |
| Low Voltage Directive Annex III | 2014/35/EU | Technical documentation for electrical equipment |
| EMC Directive Annex II | 2014/30/EU | Technical documentation for EMC |
| MDR Annex II & III | (EU) 2017/745 | Technical documentation and post-market surveillance |
| Construction Products Regulation | (EU) 305/2011 | Declaration of Performance technical file |
Often delivered together
These services are commonly scoped as part of a single engagement.
Get a realistic timeline for your global technical documentation project
In this 20-minute call, you will receive a list of applicable directives, likely testing needs, and clear next steps.