Compliance Assessment (Documentation Review & Gap Analysis)
€400
To get market access for your product, you will need to have a Technical Construction File which complies to the country-specific regulations. In close cooperation with you, we will perform a compliance assessment. This means:
- Verify the Legal Description & Intended Use
- Regulatory research: Determine the applicable Directives and/or Regulations
- Regulatory research: Determine standards
- Determine your obligations & responsibilities
- Provide list of required documentation
- Verification of the available documentation & of your supplier’s certificates and test reports (if any)
- Documentation review: Assessment of the content of the available documentation and product testing based on the applicable requirements
- Gap Analysis (what is required – what do you have)
- Assist in meeting regulatory requirements
- Compile Final Report (including findings & Advice and recommendations);
- Determine compliance or outline the follow-up steps