Quality system
Keep the company and regulatory profile facts right and provide the documents your quality system is assessed from. There is no separate process-attestation step.
4 guides
Complete the company profileCheck the company facts Complya read from your documents, correct any that are wrong, and add the ones no document gave.Complete the regulatory profileRecord the quality system certificate and your declarations — the PRRC route, the ISO 13485 position — and follow their review states.Provide quality-system evidenceAnswer your expert's requests, keep your quality documents read and tagged, and follow how each case's processes are being reviewed — without deciding acceptance yourself.Understand evidence tagsA tag says what kind of evidence a document appears to be — a proposed relationship to processes, never acceptance.