Technical File Review & Gap Analysis
€400
Purpose: The Technical File Review & Gap Analysis 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.
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 the following:
- Verify the legal description & intended use
- Determine the applicable Directives and/or Regulations
- Determine test standards
- Determine your obligations & responsibilities
- Provide list of required documentation
- Verification of the available documentation & supplier’s certificates and test reports (if any)
- 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
