Systemic Standards – 专业产品安全服务。卓越合规。

Technical File Pre-Audit & EU Representation

(Gap Analysis for CE Certification Readiness)

Would you like to appoint us as your EU Representative? In order to bindingly assess whether your products meet the legal requirements for CE marking in the EU, we conduct a fee-based Technical File Pre-Audit (Gap Analysis) beforehand.

1. Company Details (Applicant)

2. Product Details & Market History

Is the product already available on the market?
Have there been any recalls, sales bans, or safety warnings?
Is this product distributed under other brand or model names in the EU?

3. Documents & Supporting Evidence

Please upload all available documentation below. The more complete the documents are, the faster we can perform your Pre-Audit.

Tip: You can select multiple files at once or upload a compressed ZIP archive.

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Note: If sufficient insurance coverage is not yet in place, proof must be provided prior to official mandate assumption.

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4. Process and Next Steps

1. Commissioning the Pre-Audit: You will receive a quotation from us regarding the fee for the Technical File Pre-Audit.
2. Conducting the Gap Analysis: Upon acceptance, receipt of payment, and all documentation, we will cross-reference your files with current EU standards.
3. Evaluation Report: You will receive a detailed report outlining whether your documentation is sufficient or highlighting gaps and additional tests that are strictly required.
4. Onboarding & Mandate: Following a successful audit outcome (or once documented gaps have been resolved), the official mandate agreement appointing us as your EU Representative will be finalized.