ACERTA Certification and Inspection Pty Ltd (ACI) provides independent ISO 13485 certification for Australian medical device companies. We audit your quality management system against the standard and certify where the evidence supports it.

What is ISO 13485?

ISO 13485 is the international standard for quality management systems in the medical device sector. It applies across design, production, storage, distribution, installation and servicing, with strong emphasis on risk management, traceability and regulatory obligations.

What our certification involves

• Review of your quality manual, design controls and risk management file
• Assessment of production and process controls, including validation
• On-site audit of traceability, identification and records
• Review of complaint handling, vigilance and post-market activity
• Verification of internal audit, management review and CAPA
• Certification followed by scheduled surveillance audits

Why organisations certify

• Independent verification of a compliant quality system
• Expected by distributors, contract manufacturers and regulators
• Supports market access conversations in multiple jurisdictions
• Structured control of risk across the product lifecycle

Our role

ACERTA Certification and Inspection Pty Ltd is a certification body. We audit and certify — we do not design, document or implement management systems for the organisations we assess. That separation is what gives our certificates value to the customers, regulators and trading partners who rely on them.

Get started
Contact us with your sites, scope and timeframe, and we will provide a written quote covering the full certification cycle.