Build and maintain regulatory documentation from structured information. Answer once, reuse controlled data across connected documents, and keep revisions and approvals visible.
Capture a regulatory fact once, then reuse that controlled information wherever the workflow references it.
Enter a device fact, like shelf life or sterilization method, a single time.
That answer carries into every document that references it, instantly, with no copy-paste.
Sign-offs and revisions are time-stamped, so you always know what changed and who approved it.
No more late nights formatting files or fixing five documents for one small change.
Connected documents can reuse the same controlled answers, reducing repeated entry and inconsistent facts across the document set.
Know which documents need updating when something changes.
Change a device specification and see which connected documents may be affected, such as the GSPR checklist, Risk Management File, IFU and Clinical Evaluation Report. Reduce manual cross-checking and missed updates.
Share a link with a client or supplier. They answer in their browser, no login needed, and it flows straight into your documents.
45+ document types across 10 categories, organized the way your team already works.
Export your whole document set as a single ZIP, each file a clean, correctly formatted Word document. No fixing fonts, spacing or headings by hand.
Highly customizable, down to the document set and approval chain. Already run other tools alongside your regulatory work? We can integrate those too.
A product workspace built around the way regulatory information actually moves: collect it once, connect it, review it and turn it into reusable documentation.
Capture device facts through guided questions and organized tables.
Reuse the same controlled answer wherever that fact is required.
Build DD, GSPR, LOAS and the wider technical documentation set.
Keep revisions, comments and approvals attached to the work.
Export clean documents when the team is ready to use them.
AeshReg turns recurring regulatory facts into reusable controlled data instead of asking your team to maintain the same answer across separate files.
Give clients or suppliers a focused intake link so they can provide the information you need in a structured format.
Keep document revisions and approval states visible instead of hiding the history inside filenames and shared-drive folders.
From administrative basics through post-market surveillance, each category keeps its own documents grouped, versioned and ready for review.
Build and maintain the technical documentation set from structured, reusable product information.
Review controlled content, follow revisions and keep approvals visible in the same workflow.
Provide requested information through focused intake links instead of long email chains and disconnected spreadsheets.
| Shared drives & Word | AeshReg | |
|---|---|---|
| Shared data | Copy-pasted into every file by hand |
One answer, linked into every document |
| Versions | Files named "final_v3_FINAL" |
Full revision history, with sign-off |
| Client input | Back-and-forth over email |
A link they fill in directly |
| Document set | Templates you build and maintain |
45+ documents, organized and ready |
Whether you are replacing spreadsheet-driven documentation, standardizing a growing document set, or exploring a connected workflow for your team, we’d like to understand how you work today.
Share a little about your organization, device portfolio, or current documentation process and we can continue the conversation from there.
Emailbusiness@apexelites.in ↗