​From MedTech Innovation to Compliant Market Access.                                     

Upload your MedTech documentation and get a free, high-level, structured, practical feedback before you submit it or face an audit. We focus on structure, completeness, clarity, and alignment with EU MDR, ISO 13485 and ISO 14971 expectations.

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What we can review.

 

Documentation Check (sample documents)

• Quality system documents (SOPs, work instructions, templates, forms)

• Technical documentation sections and annexes

• Clinical, PMS, and PMCF documentation drafts​

 

Registration Dossier Check (selected sections)

• EU MDR technical documentation for submission

• Registration dossiers and country‑specific application packages

• Cover letters, checklists, and supporting summaries

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 Traceability & Consistency Check (sample documents)

• Risk management file and GSPR matrix

• IFU, labelling and warnings, checked against your risk management and GSPR claims

• Clinical evaluation, PMS, and PMCF documentation

• Cross‑references and traceabilitylinks between technical documentation sections, risk management, clinical evidence, and PMS/PMCF reports.

 

If you are unsure which option fits best, simply select both and explain your situation briefly in the message field. If you prefer, you can also paste a secure link to your documents in the message field instead of uploading them, provided your internal IT and data protection policies allow this.

This free check is designed for a small, representative set of documents (typically up to 2–5 files or sections) so we can highlight the most relevant issues and opportunities. A more in‑depth, full‑set review can be arranged as a separate service.

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How the review works.

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1. Upload your documents or paste a secure link, and describe your device, target markets, and current stage.

2. We assign your request to the right specialist 

3. You receive structured feedback, priority findings, and clear next steps within an agreed timeline.

This is a focused, preliminary review of a limited number of documents and is not a full gap assessment or full technical documentation review. If you need a comprehensive analysis or support with implementing changes, we can propose a tailored consulting package

 

 

Confidentiality and data protection.​​

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Your files are treated as strictly confidential and handled in line with GDPR and professional industry practice. We use them only for reviewing your documentation and providing tailored advice.