By purchasing this service you will get the first two steps in our three-step approach to product compliance for one product:
- Requirement analysis
The most important step for achieving compliance is finding the product’s requirements. In this step we analyse the product and find the relevant directives, regulations, standards and any mandatory registrations that needs to be made.
- Gap analysis
When knowing the requirements, the next step is to determine the current status, which is done by comparing the product’s documentation with the requirements. Any discrepancy? This is a gap! After this step, you will know all the actions you need to take to reach compliance.
- Closing the gaps
After finding gaps, we need to close them. This is done by compiling the technical documentation, performing tests at test labs, creating the user instruction, doing any necessary registrations, and finally signing the necessary documents to comply with the legal requirements.
With these steps completed, you are ready to sell your products on the EU market. You need to be prepared to provide all (non-proprietary) documentation regarding the product (if you want we can sign an additional NDA (our own template or yours) so we can speak freely).
Types of products
Included in the range of this service is most types of non-food products except cosmetics, biocides and medical devices. Production lines are also excluded as these require a different setup.
Please contact us directly if you need support in any of these fields.
What is included in the service
When purchasing this service you get the first two steps of our process. In each step, you will get the following answered (among other things):
- Requirement analysis:
- Must the product be CE marked and if so, how?
- Which directives, regulations and standards are relevant?
- Does a Notified Body (third party certification) need to be involved?
- Does the product (or the company) need to be registered somewhere?
- Gap analysis
- Do we have documentation that cover all requirements identified in step 1?
- If relevant, are all certificates and test reports legitimate?
Advantages of purchasing this service
- You will know what requirements are laid on the product
- You will know if you comply with the requirements and if not, how to comply.
What we deliver are clear and simple reports in word, pdf and excel with clear actionable tasks so you may continue working to close the gaps if there is a need (of course we can help you with that as well.)
Your investment
The cost for a gap analysis is 1490€ and it always includes both requirement analysis and gap analysis.
Delivery time is approximately 20 working days but may differ depending on your needs, the complexity of the product and our work load.
Product
The process
- Once you have purchased the service, you will get a confirmation email.
- After that we will as soon as possible reach out and schedule an appointment to start the process.
- You will send us the relevant documents per our instructions.
- We will do the initial review and start the dialog with you and other relevant parties to complete the process.
- Once completed, we will send you the requirement analysis as a separate deliverable.
- You then need to provide us with documentation to match the requirements.
- Once you confirm that you have provided us with all relevant documentation, we conduct the gap analysis and send you the report.