Nine tools and a portal for regulatory affairs, built with Claude. They fill in templates, generate declarations of conformity and check references. Local in the browser, with no AI at runtime.
Result
Roughly between May and October 2026, nine tools and a portal came out of this: four tools are ready for use, five are in a test phase, and the portal is in use. I have not measured time savings for any of the tools. Two test runs with real data are documented. The declaration of conformity generator correctly split an item list with a three-digit number of items into three declarations, and the Word files open without a repair prompt. The tool for the technical documentation summary transferred several hundred reference lines from a real file into the right sections and marked unreleased documents exactly. A sample chapter was identical to the version made by hand.
Starting point
I work in regulatory affairs at a medical device manufacturer. Technical documentation, EU declarations of conformity, labelling and change management under the EU Medical Device Regulation (MDR) were largely maintained by hand there: copying data from ERP and DMS exports into Word and Excel templates, looking up references one document at a time, finding contradictions by comparing line by line. That takes time, and errors easily go unnoticed. There was no server for providing in-house tools centrally.
What was built
Nine tools and a portal that bundles them, each a single HTML file. I built them directly within the department, for the regulatory affairs team and for colleagues working on technical documentation. They all follow the same rules:
- Local and offline. The tools start with a double-click in the browser, with no installation, server or internet. All libraries are included, and no data is uploaded.
- A human decides. The tools suggest, mark and comment. They never overwrite existing values silently, and regulatory decisions stay with a human.
- Templates stay as they are. Given Word and Excel templates are only filled in. Formatting and print areas stay unchanged.
- No AI at runtime. The tools work rule-based, deterministically and traceably. I chose this on purpose for a regulated environment.
- Bilingual and versioned. Interface in German and English, a visible version, a change log and a maturity level: “ready for use” or “test phase”.
Creating
- Filling in and reconciling the item list. Reads ERP exports and the existing item list of a product family and fills in the given Excel template. Regulatory fields come only from the existing list; nothing is made up. Plausibility rules detect, among other things, shifted columns, codes in the wrong column and discontinued items.
- EU declarations of conformity. Groups the items by risk class or subclass and generates one declaration per group from the given Word template. Notified body, assessment procedure and certificate details are derived by fixed rules. Before anything is generated, everything appears in an editable preview.
- Justification for the change history. Filters the change export by period and status, splits the entries into two tables and generates the justification document from them. Changes reported to the notified body are marked.
- Labelling justifications in batches. Generates one document for each combination of product file and instructions for use, with a de-duplicated, sorted list of items. Designed for runs of several hundred documents.
- Summary of the technical documentation. Fills in only the reference tables from the file export, as a suggestion. Unreleased documents are marked yellow, and a coverage report shows what went where. Shortening and curating stay with a human.
- Manufacturing process flowcharts. Draws the diagram from an Excel table, with external steps, inspections, cleanroom and validations clearly marked, and exports it as SVG, draw.io, PNG or PDF. I developed this tool further together with colleagues.
Checking
- Packaging specifications. Three sub-tools reconcile the item list, the specifications and the DMS metadata: which items are not covered, which metadata do not match?
- References and identifiers. A reference check looks up every source of a biological risk assessment in the product file. A validation check compares the validations in the manufacturing process report with the file in both directions. An extractor collects document identifiers from any number of documents and unifies how they are written.
Deciding
- Symbol assistant. Plain questions such as “sterile?” or “single use?” lead to a table of the matching standardised symbols, with the standard reference and a status: mandatory, conditional or recommended.
Providing
- Tool portal. The entry point asks what you want to do: decide, check or create. It adds search, a glossary for abbreviations and the maturity level of each tool.
