Explicio brings regulations from medical device law, data protection and quality management together as linked knowledge, so that health and social care organisations always have the current version with its reference at hand. The assistant names conflicts between requirements when the content is brought in, not only during the audit.

WZ QKNOWLEDGE · HEALTH AND SOCIAL WORK

Conflicting regulations: Who knows the current version?

Compliance, legal & quality management

You maintain the quality management manual while simultaneously needing to integrate the latest requirements of medical device law and the GDPR. Often, relevant information is scattered across emails, old manuals, and internal notes.

SITUATIONConstantly searching for the right source wastes time. When regulations change or conflict, there is a high risk of errors in documentation. Double handling and outdated knowledge hinder daily work in quality management.

THREE KNOWLEDGE ISLANDS

Where this knowledge sits.

Three situations that keep coming up in this industry — no metric, no promise.

REGULATIONCurrent regulatory requirementsStandards and laws change frequently. There is a risk that outdated versions are used as the basis for audits because the current version cannot be found centrally.
DOCUMENTATIONQuality Management ManualThe manual is dynamic but often stored statically. Changes to processes do not automatically find their way into central documentation, leading to inconsistencies.
RISKMedical Device Risk ManagementRisk assessments must be aligned with current safety requirements. A lack of transparency regarding the sources of risk assessments jeopardises traceability.

WHAT HAPPENSWhen you input documents, emails, or voice messages into the system, it automatically links this content. The assistant checks the inputs and explicitly identifies conflicts between different regulations, rather than smoothing them over. Every answer includes the exact reference, allowing you to verify the source immediately. This ensures that compliance documentation remains current and traceable.

Self-check — loads when visible.

ASKED

What businesses in this industry ask.

How do I find the current version of regulatory requirements?

The system searches all imported sources and provides the reference with page number or timestamp. You receive the information directly from the context of the imported documents, without manual searching.

How do I update the quality management manual efficiently?

By importing new guidelines or changes as documents or emails, the system links these with existing processes. The assistant indicates where adjustments are needed and cites the source.

How do I demonstrate risk assessment for medical devices?

Through the central storage of all relevant risk documents and protocols. The system helps identify inconsistencies in assessments and provides evidence for audits with the respective source.

WHAT EXPLICIO DOES NOT DO HERE

Limits that apply — even when nobody asks.

  • Explicio grants no approval and signs no record.
  • Explicio does not decide which requirement applies — it names both sources.
  • Explicio replaces neither an audit nor legal advice.
What Explicio does not evaluate — for works councils and data protection →
MORE IN THIS CONTEXT

The same question from two directions.

TECHNICAL DIAGNOSIS · DEMO WITHOUT A CALL

Bring in knowledge first. Then decide.

After a short conversation we set up your trial space. Then bring in one voice note or file from your business — and see where the first knowledge island sits. The 30 days start only after that.

Term
30 days from your first knowledge
Cost
0 €
Licence
none — we bill the knowledge, not the seat
Service statusTo the live status page →