What Article 16 Requires
Providers must ensure conformity, quality systems, documentation, controls, and post-market obligations before and after placing systems on the market.
How VCCL Answers
- Acts as a compliance execution layer for provider governance workflows.
- Builds evidence pipelines that support conformity, monitoring, and accountability obligations.
- Creates verifiable records to support notified-body and authority interactions.
Legal Questions and VCCL Responses
VCCL delivers deterministic traceability and signed records that evidence operational control and auditability.
Yes. VCCL unifies runtime audit traces and documentation artifacts in one workflow.
Yes. Lifecycle records are retained and exportable for investigations, remediation, and authority requests.