Quality system
Maintain manufacturer profile facts and provide evidence for QMS obligations. Your quality system is assessed from the documents you provide — there is no separate process-attestation step.
4 guides
Complete the company profileProvide manufacturer identity, people, activities and operating details as facts the platform records and reuses.Complete the regulatory profileRecord PRRC and ISO 13485 declarations and follow their review states.Provide quality-system evidenceUse the coverage table and document library without deciding acceptance yourself.Understand evidence archetypesUse plain-language source categories as a proposed relationship, not as acceptance.