Ensure quality and regulatory compliance for medical device manufacturers and suppliers with the international standard for medical device quality management systems.
ISO 13485 is the international standard for Quality Management Systems specific to the medical devices industry, published by the International Organization for Standardization. It specifies requirements for organizations involved in the design, production, installation, and servicing of medical devices and related services.
The standard is harmonized with regulatory requirements in major markets including the EU Medical Device Regulation (MDR), US FDA Quality System Regulation (21 CFR Part 820), and Health Canada Medical Devices Regulations. It focuses on risk management, product safety, and regulatory compliance throughout the device lifecycle.
ISO 13485 certification is often a prerequisite for market access, regulatory approval, and procurement by healthcare providers. It demonstrates your organization's capability to consistently meet customer and regulatory requirements for medical devices.
International Standard for Medical Device QMS
Discover how ISO 13485 creates value and supports regulatory compliance in the medical device industry.
Meet requirements of EU MDR, US FDA, Health Canada, and other regulatory authorities worldwide.
Facilitate market entry and product registrations across global markets with internationally recognized certification.
Ensure device safety and effectiveness through systematic risk management and quality controls.
Implement robust design controls, production controls, and validation processes for medical devices.
Demonstrate capability to OEMs, contract manufacturers, and healthcare procurement bodies.
Systematically monitor product performance, analyze complaints, and implement corrective actions.
A structured, step-by-step path to achieving your ISO 13485 certificate with ISOQACERT.
Assess current quality management practices against ISO 13485:2016 and applicable regulatory requirements.
Identify applicable regulatory requirements for target markets (EU, US, Canada, etc.).
Implement ISO 14971 risk management processes for medical device development and production.
Develop quality manual, design controls, production procedures, and device master records (DMR).
Implement processes, validate production processes, and conduct design verification/validation.
Conduct internal QMS audits and management review of system effectiveness.
Stage 1 and Stage 2 audit by ISOQACERT/LL-C auditors; certificate issued upon successful completion.
ISO 13485 is applicable throughout the medical device supply chain.
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Certified ISO 13485 Lead Auditor and Lead Implementer training programs through our Exempler or ERCA-accredited training division.
Demonstrate quality and regulatory compliance for medical devices.
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