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ISO 13485:2016

ISO 13485 Medical Devices QMS

In order to ensure the safety and efficacy of medical devices, manufacturers must adhere to a number of strict quality standards.

What this programme covers

ISO 13485 Medical Devices QMS provides an independent framework for organisations that need credible evidence of control. UBIAC assessments are impartial and objective — designed to give your customers, investors, and partners confidence in your systems.

When the programme completes, UBIAC issues a certificate for this service. Anyone can confirm it on the public Verify page. Engagements run in your client portal: document collection, audit scheduling, findings, issuance, and renewal reminders.