REQUIREMENTS & GAP ANALYSIS
Understand What Applies to Your Product
Identify applicable requirements, review existing evidence and understand what may still be missing.
We help you determine the regulatory requirements that apply to your product and target market, review the compliance information you already have and identify potential gaps before deciding what needs to happen next.
Part of our End-to-End Product Compliance Support, or available as a focused standalone review.

WHAT WE REVIEW
A Clear View of Your Compliance Requirements
The review is built around your actual product, target market and existing compliance information. The objective is to understand what applies and where additional action may be needed.
Product Classification
Review of intended use, product category, target users and relevant characteristics.
Applicable Regulations
Identification of the legal requirements that may apply in the selected market.
Applicable Standards
Identification of relevant standards or technical specifications that may apply to the product.
Existing Evidence Review
Review of available test reports, technical information, labels and other compliance evidence.
Compliance Gap Analysis
Identification of missing, incomplete or potentially unsuitable compliance evidence.
Practical Next Steps
Clear actions explaining what may need to be reviewed, updated, tested or prepared next.
WHEN THIS SERVICE IS USEFUL
When Requirements Are Not Yet Clear
A Requirements & Gap Analysis can be useful at different stages of the product lifecycle, especially when you need clarity before making further compliance decisions.
Get clarity early and make confident decisions.
Before Launching a New Product
Understand the compliance route before committing to testing, documentation or production changes.
When Entering a New Market
Identify how requirements may differ from markets where the product is already sold.
When Existing Documentation Is Incomplete
Understand what evidence is already available and what may still be missing.
Before Commissioning Additional Testing
Determine what testing or evidence may actually be required before spending money unnecessarily.
WHAT YOU RECEIVE
Clear Findings and
Practical Next Steps
You receive a clear review of applicable requirements, existing evidence, identified gaps and practical next steps.
Applicable Requirements
A clear summary of the regulatory requirements identified for your product and target market.
Relevant Standards
Standards or technical specifications identified as relevant to the review.
Existing Evidence Status
A clear view of the compliance evidence already available and how it relates to the identified requirements.
Identified Compliance Gaps
Missing, incomplete or potentially unsuitable evidence, documentation or product information.
Recommended Next Actions
Practical actions explaining what should be reviewed, updated, tested or prepared next.
Example project workspace. No real client information.

FAQ
Common Questions About Our
Requirements & Gap Analysis Service
Quick answers to the questions we hear most often. If you need more information, feel free to get in touch.
READY TO MOVE FORWARD?
Start With a Clear View of What Applies
Tell us about your product, target market and the compliance information you already have. We’ll help you identify the applicable requirements, potential gaps and practical next steps.
We normally reply within one business day.
