What is the cost of ISO 13485 certification?

The cost varies widely based on your organisation’s size, medical device complexity, number of sites, and selected accredited certification body, with smaller providers starting around a few thousand USD and larger implementations significantly higher.

Which countries require ISO 13485 certification?

No single country legally requires ISO 13485 for all devices, but many regulators (like the EU for CE marking) and markets (Canada, Australia, Japan, and others) mandate or strongly prefer it for market access and quality evidence.

Who regulates medical devices in Qatar?

Medical devices in Qatar are regulated by the Qatar Ministry of Public Health (MOPH) through its Health Regulation Department, which oversees safety, registration, and compliance standards (including ISO alignment).

How do I get ISO 13485 certification?

You implement a compliant Quality Management System, undergo internal audits, and then schedule an external audit with an accredited certification body; passing both stage 1 and stage 2 audits earns the certificate.

How long is ISO 13485 certification valid?

This certification is typically valid for three years, with annual surveillance audits to confirm ongoing compliance.

How much does it cost to get ISO certified?

ISO certification costs vary by standard and scope; for ISO 13485, they depend on company size, QMS maturity, number of audit days, certification body fees, and initial certification, surveillance, and recertification costs.