Turn Existing Documentation Into a Structured Technical File.
Whether you already have technical documentation or are starting without a
structured file, we can create a new technical file or review and structure what is
already in place. We identify missing or inadequate evidence and organise the
available information into a clear, controlled technical record.
Establish What Is Required, What You Already Have and What Is Missing.
You may already have a product, technical documentation and a route to market in mind. Our Technical File
Review & Compilation provides an early review of your product and the information available, identifying potential
regulatory and compliance issues that may need attention before the product is placed on the market.
What Does the Technical File Require?
We establish the documentation and supporting evidence required for the product, taking account of the applicable regulatory requirements and conformity assessment route.
What Documentation Is Already Available?
We review the information supplied by the manufacturer and assess whether it provides the evidence needed to support the applicable compliance requirements.
What Is Missing or Needs Attention?
We identify documentation that is missing, incomplete or inadequate, and define what must be provided, updated or developed to complete the technical file.
How the Assessment Works
Define Product & File Scope
We confirm the product, intended use, configuration and market, then determine whether a new technical file should be created or the existing file reviewed and restructured.
Review Existing Documentation
We review the drawings, risk information, calculations, test evidence, instructions, declarations and other records supplied.
Identify Evidence Gaps
We identify missing, incomplete, outdated or inadequate technical documentation and define what is required.
Address Outstanding Information
We structure or update documentation where appropriate and identify evidence that must come from the manufacturer, supplier or test body.
Compile & Control the Technical File
We organise the evidence into a structured technical file and establish a Critical Document List recording key documents, revisions and status.
At every stage, the technical file shows what has been reviewed, what is accepted, what remains outstanding and who needs to take the next action.
A Structured Technical File With Clear Document Status.
The objective is not simply to collect documents. We organise the available evidence into a clear technical file,
identify what is missing and define the actions needed to complete the record.
Manufacturers Preparing for Market Access
Businesses that want their technical documentation reviewed before placing products on the market.
Companies With Existing Technical Files
Manufacturers looking for an independent assessment of documentation already prepared.
Businesses Addressing Documentation Gaps
Companies that need help identifying missing, incomplete or inconsistent compliance information.
Technical file requirements and structure
Outstanding manufacturer or supplier actions
Existing documentation reviewed and indexed
Evidence status linked to requirements
Document and evidence gaps identified
Structured technical file and action list
Your Technical File Status Is Available Through the Client Portal
See what has been reviewed, what has been accepted, what remains outstanding and who needs to take the next action.
GLOBAL CE MARKING | CLIENT PORTAL
Technical File Review & Compilation
Example Technical File Status
Assessment ref: PCA-1047
24
Documents reviewed
18
Complete
6
Outstanding
Product description & specifications
Complete
Risk assessment
Safety calculations
Evidence required
Instructions & labelling
IMPORTANT
Where technical evidence must come from the manufacturer, designer, supplier, test laboratory or another competent party, we identify the required evidence and track it as an outstanding action.
CONTROLLED TECHNICAL RECORD
Critical Documents, Properly Controlled
As the technical file is compiled, we establish a Critical Document List identifying the key documents and evidence
relied upon to support the product compliance position. Each document is recorded against its reference, revision
and status, creating a controlled baseline that can be maintained and audited.
Critical Document
Reference
Revision
Status
Risk Assessment
RA-001
C
Current
Electrical Drawings
EL-004
B
Current
Safety Calculations
SC-002
A
Action Required
Declaration of Conformity
OI-001
D
Revision Required
Declaration of Conformity
DOC-001
Draft
Pending
Controlled
Critical compliance documents and their current revisions are clearly identified.
Maintainable
When documents or the product change, the controlled baseline makes the affected compliance evidence easier to identify and review.
Auditable
The list provides traceability to the specific document revisions forming part of the technical file record.
Document
Reference
Revision
Status
Action
A controlled compliance baseline
RISK ASSESSMENT SUPPORT
Need Support With the Risk Assessment?
Risk assessment is a key part of the technical evidence within the file. Where needed, we can review an existing
assessment, help compile a new one with your technical team, and identify actions arising from the findings.
Review & Gap Assessment
We review the assessment against the product and available technical evidence, identify gaps and record any actions needed.
Risk Assessment Compilation
We work with your technical team to develop and document a structured assessment using the available product and design information.
Risk Reduction Support
Where further controls, evidence or documentation are required, we define the actions and link them back into the technical file.
GLOBAL CE MARKING | CLIENT PORTAL
RA-001 | Revision C
Hazard identification
Reviewed
Risk evaluation
Reviewed
Protective measures
2 actions
Residual risks
1 action
Instructions cross-check
Review required
Risk
Control Measure
Technical Evidence
Critical Document
Traceable by design
For Manufacturers Who Need to Create, Complete or Restructure Their Technical File.
Entering the EU or UK Market
Understand potential regulatory obstacles before investing heavily in market entry
Launching a New Product
Get an independent early-stage check for compliance issues that may need attention.
Unsure About Existing Compliance
Identify obvious concerns in current documentation before moving forward.
Keep the Technical File Clear, Structured and Actionable.
A structured technical file makes it clear what evidence supports the product, what remains outstanding and what
action is needed. If the product changes later, the compliance impact can then be reviewed against this
established record.
Product Compliance Assessment
Identify potential compliance issues and areas that may need further attention.
Technical File Review & Compilation
Review, complete and organise technical evidence
into a structured compliance record.
Product Change & Compliance Review
Assess how changes affect established compliance, documentation and supporting evidence.
Clear Communication
Direct, responsive and straightforward feedback.
Practical Compliance Support
A practical approach focused on real-world documentation requirements.
Confidential Handling
Your technical information is handled securely and treated with care.
Understand Your Product
We take time to understand your product and its intended use before reviewing the documentation.
Common Questions
Find quick answers to key questions about our Technical File Review service.
What documents are included in a technical file?
The required documentation depends on the product and applicable legislation, but may include product descriptions, drawings, specifications, risk assessments, test information, instructions and declarations.
Can you review a technical file that is already complete?
Yes. We can independently review an existing technical file to identify potential gaps, inconsistencies or areas requiring further attention.
What happens if you identify missing documentation?
We provide clear feedback on the areas identified during the review so you can understand what may need to be added, updated or clarified.
Do you create the technical file for us?
This service focuses on reviewing your existing technical documentation. Where additional support is required, we can discuss the appropriate next steps based on your requirements.
Need Your Technical File Reviewed?
Talk to our team about your product and existing documentation. We’ll help you identify potential gaps and understand the next steps towards a stronger technical file.
Responsive Communication
We aim to reply promptly.
Expert Guidance
Speak directly with our specialists.
Confidential Service
Your information is always secure.