For regulatory leaders
Generated from your source data, always current, and the moment anything changes you see the regulatory impact across every market.
An Avera Docs document over the system of record: it reflects the latest design instead of a stale snapshot, and is never reconstructed. Documents →
Change a design input or BOM line and instantly see which sections, filings, and markets are hit: re-file, letter-to-file, or significant change.
Each market's authorization record carries the decision and links to the device version it covers; release is gated where approval must come first.
Load each standard you own as a clause tree; conformity is a live matrix (clause ↔ evidence), not a binder rebuilt before every audit.
A supplier or design input changes. Instantly see which technical-file sections, which filings, and which markets are affected, and whether it's a letter-to-file or a significant change, before it becomes a surprise at audit. The decision lands as a record per market.
Living documents produce submission-ready output from source; let's confirm pack depth against your target markets.
Avera holds the decision, the submission content, and the authorization records, and pulls vigilance data in; filing itself stays with you and the authority.
Evidence that is current by construction, decisions as records, and an append-only trail they can read.