Every new standard, another evidence trail built by hand

Regulatory complexity multiplies as you grow

Your quality system passed its last audit. Then you sell into Canada and MDSAP becomes mandatory, a sponsor audit asks for ICH E6 R3, or your next product has software in it and IEC 62304 arrives with it. Most of what the new standard asks for, you are already doing. But the only way to find out which controls already answer it is a clause-by-clause review by hand.

One standard becomes several

QMSR, ISO 13485, EU MDR, MDSAP, ICH, each with its own clause list and spreadsheet

Finding the gaps is a manual review

Someone reads every clause against every record, or you pay a consultant to.

The same evidence, standard by standard

Effort spent twice, and the gaps in the overlap are the ones an auditor finds first.

THE STAKES

Every standard you add costs months, consultants and headcount.

ONE EVIDENCE BASE, ASSESSED AGAINST EVERY STANDARD

Add a standard without starting over

Qualio breaks every standard down clause by clause and automatically assesses your records against each one.

One control can satisfy several standards at once, so when you add a standard you see what your existing controls already cover, what is new, and where the gaps overlap. And it reads the records where they live: in Qualio, in your document store, or in a QMS you already run.

The Results

80%

Less audit prep time. A week became a day.

Sentec

Compliance coverage.

Cogstate

6 months

ISO 13485 in 6 months, with no added quality headcount.

Cardiaccs

How it works

Find it. Fix it. Prove it closed.

Choose the standard from the catalog, or build your own. Then point it at your policies and records: connect your QMS or document store, or upload the files yourself.

AI reads each record against each clause of the standard and returns findings. Every finding cites the clause it applied and the record it read.

Every finding carries a recommendation, and Copilot drafts the fix from it: the procedure update, the change control, the CAPA, the tasks for the people who own them. Your team reviews and approves.

A fix lands, a procedure is revised, a supplier is qualified. Qualio reassesses, confirms what closed, and flags what drifted.

Growing framework library

The standards you're audited against, already mapped

In the library:

ISO 13485
EU MDR
MDSAP
IEC 62304
ISO 14971
ICH Q7 to Q11
See the full catalog

Plus a custom framework builder for the internal standards only your team carries.

View all frameworks

Qualio frameworks screen with active frameworks including FedRAMP, IEC 62304, ISO 27001, ISO 27701, ISO 9001 and SOC 2, each with its requirement status

Continuous compliance

The assessment never stops running.

A gap assessment is a snapshot. Revise one procedure or change one supplier and it is stale, and nobody finds out until the next audit. Qualio reruns the assessment whenever a record changes and flags any gap it opens. An audit running around the clock, with your team seeing the findings before an auditor does. And when the real one lands, you export the pack: every policy and piece of evidence, organised clause by clause the way the auditor reads it.

Reassessment triggered by a record change, not by a calendar date
Fixes verified on the next run, so a closed gap stays closed
Cross-framework view of where standards overlap and diverge, reported from live data
Audit pack export: every clause, with the policies, evidence and approvals behind it
Plan the next internal audit from the clauses with open gaps. See audits.