Compliance Assessment (Documentation Review & Gap Analysis)

Purpose: The Compliance Check aims to ensure compliance with the legal framework thorough deep research on the directives and regulations, further review of documents and your product, and the assessment of marketability, providing specific advice on the current legal situation.

Scope:

We will create a customized report for you, in which we explain in detail the steps that must be taken to comply with the regulations.

• Creation of a detailed report with recommendations for action
• Provision of an individualized Compliance Sheet
• Requesting the necessary information and documents
• Review of products/product packaging
• Examination of compliance documents for completeness and conformity
• Checking for potential marketability

Steps:

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