Cert360 provides expert ISO 13485 certification services in Australia, helping medical device manufacturers, suppliers, and distributors implement robust quality management systems that ensure compliance with regulatory requirements and international best practices. Our services enable organisations to maintain consistent product quality, improve safety standards, and demonstrate regulatory compliance across all stages of medical device design, production, and distribution.
Our ISO 13485 approach integrates regulatory compliance, risk management, and quality control processes into organisational workflows. By implementing structured quality management systems, businesses can reduce product defects, enhance operational efficiency, and gain stakeholder confidence, including healthcare providers, regulators, and patients.
ISO 13485 is an international standard for quality management systems specifically designed for medical device manufacturers and related organisations. It sets out requirements for regulatory compliance, risk management, and consistent production processes to ensure the safety and effectiveness of medical devices.
Applicable to organisations across the medical device supply chain, ISO 13485 certification supports compliance with national and international regulations, improves product quality, and ensures operational reliability. Certified organisations demonstrate a commitment to patient safety, quality assurance, and regulatory adherence.
ISO 13485 certification demonstrates that an organisation maintains a quality management system aligned with regulatory requirements for medical devices. Certified organisations can improve product consistency, reduce defects, and strengthen trust with healthcare providers, regulators, and patients.
Certification also ensures adherence to Australian Therapeutic Goods Administration (TGA) regulations and international regulatory standards. Organisations accredited to ISO 13485 are recognised for robust quality management, regulatory compliance, and a proactive approach to patient safety and operational excellence.
We assess current medical device quality management processes, documentation, and regulatory compliance against ISO 13485 requirements to identify gaps and improvement areas.
Our consultants develop customised procedures, policies, and records for production control, risk management, traceability, and regulatory compliance aligned with ISO 13485.
We assist organisations in implementing quality management controls, risk assessment protocols, and operational procedures to meet ISO 13485 requirements.
Internal audits verify compliance with regulatory standards, staff competency, and process effectiveness prior to certification assessment.
We provide comprehensive support during the certification audit, including evidence preparation, staff guidance, audit coordination, and addressing non-conformities.
We review medical device processes, regulatory obligations, and operational workflows to define a clear ISO 13485 certification scope tailored to your organisation.
Processes, documentation, and compliance measures are evaluated to identify gaps, potential risks, and opportunities for quality improvement.
Quality management policies, process controls, risk assessments, and monitoring systems are implemented across relevant operational areas.
Staff receive training on ISO 13485 standards, quality management processes, and regulatory requirements. Internal audits verify readiness for certification assessment.
The external certification audit is conducted, non-conformities are addressed, and ISO 13485 certification is granted upon successful compliance verification.
ISO 13485 ensures organisations maintain consistent production processes, reducing defects and improving patient safety.
Certification demonstrates adherence to Australian TGA regulations and international medical device standards.
Structured processes, monitoring systems, and staff accountability optimise production workflows and quality control measures.
Systematic identification, assessment, and mitigation of risks strengthen product reliability and operational safety.
Ongoing monitoring, internal audits, and corrective actions support continual enhancement of quality management systems and regulatory compliance.
Partner with Cert360 to implement a structured quality management system for medical devices that ensures compliance, improves safety, and strengthens operational excellence. Our consultants guide organisations through every stage of certification with practical expertise, actionable strategies, and Australia-focused solutions.
Cert360 is trusted by medical device manufacturers, suppliers, and distributors across Australia for delivering comprehensive ISO 13485 certification services. Businesses rely on our expertise to maintain quality, improve regulatory compliance, and ensure certification confidently.
As a leading ISO 13485 service provider, Cert360 supports organisations seeking practical, scalable, and audit-ready quality management systems aligned with international standards and regulatory requirements.
Discuss your quality management objectives, regulatory compliance requirements, and certification needs with our experts. Cert360 provides tailored ISO 13485 solutions supporting compliant, safe, and high-quality medical device operations.
ISO 13485 certification ensures organisations implement structured quality management systems to improve product consistency, regulatory compliance, and operational efficiency while maintaining patient safety and stakeholder confidence.
Our team provides structured guidance, practical documentation, and full audit support from planning to certification. Speak with our consultants to understand ISO 13485 requirements tailored to your organisation and industry.
Leadership commitment, quality policies, internal audits, and continual improvement processes for medical device operations.
Production control, risk management, traceability, supplier management, and monitoring systems.
Performance evaluation, audit monitoring, and management review to ensure system effectiveness and continual improvement.
Corrective actions, process optimisation, and continual enhancement of quality management systems for medical devices.
An international standard specifying requirements for quality management systems for medical device manufacturers, suppliers, and distributors.
By implementing a compliant quality management system and successfully completing a certification audit.
Improved product quality, regulatory compliance, operational efficiency, patient safety, and continual improvement.
Professional support for implementing, auditing, certifying, and maintaining quality management systems for medical devices.
Services supporting management system implementation, audits, certification, and ongoing compliance.
