Manufacturers, assemblers, importers, distributors, service providers and critical suppliers can seek certification where their activities fall within a defined medical device QMS scope.

No. ISO 13485 is tailored to medical devices and places greater emphasis on documented controls, regulatory requirements, traceability, validation and risk.

An exclusion may be possible when design is not the organisation's responsibility and the exclusion is permitted and justified within the applicable scope.

It is controlled information for a device type or family describing specifications, processes, installation, servicing and other records needed to demonstrate conformity.

Evaluation should consider the supplier's effect on device conformity, capability, quality history, controls, change notification and monitoring evidence.

Validation is required when process results cannot be fully verified by later monitoring or measurement, or where deficiencies may become apparent only after use.

Complaints are documented, evaluated, investigated where appropriate and assessed for reporting, corrective action and feedback to risk management.

Yes. Risk-based approaches are expected across QMS processes, and product risk management should be linked to applicable device requirements.

Yes. Their scope may focus on supplier control, storage, transport, traceability, complaints, field actions and regulatory communication.

Qualitcert can support scope definition, documentation, supplier controls, CAPA, traceability, internal audit and certification preparation.