Evidence for systems that carry regulated work.
Source-backed reporting and analysis connected to the companies, capabilities, authorities, and operating domains it affects.
Greenlight Guru presents a medical-device platform connecting design controls, risk, product traceability, documents, training, suppliers, quality events, and CAPA. Linked evidence can make a release review reconstructable, but the links do not establish that requirements were met or authorize a device to move forward.
ISO's current record defines a medical-device quality-management-system standard for organizations across the lifecycle. It does not certify an application or make a configured workflow conforming by itself.
Articles 83 through 86 connect device-lifecycle surveillance, technical documentation, corrective action, and class-specific reporting instead of leaving post-market data in a separate complaint archive.
The transition moves actor, device, certificate, and market-surveillance records from voluntary use into required EU operating workflows, increasing the cost of disconnected regulatory data.
