ISO 13485 certification
Demonstrate quality and compliance for medical devices with internationally recognised ISO 13485 certification.
Organisations in the medical device supply chain must demonstrate control of quality, safety and compliance. Customers, regulators and supply chain partners expect well-managed processes for design, production, storage, distribution, installation and servicing.
ISO 13485 certification demonstrates that your quality management system meets an internationally recognised standard for medical devices. It supports a structured approach to processes, risks, documentation and legal requirements.
Bureau Veritas Certification provides experienced auditors, a dedicated contact and a clear process from planning to certificate issuance.
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Manage quality and risks
Manage processes, risks and responsibilities systematically, supporting consistent quality throughout the medical device life cycle.
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Demonstrate compliance with requirements
Address customer, legal and regulatory requirements through a quality management system designed for the demands of the medical device industry.
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Build stakeholder confidence
ISO 13485 certification demonstrates a professional approach to quality and safety, building confidence among customers, suppliers, regulators and other supply chain partners.
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Strengthen documentation and traceability
The standard emphasises process control, documentation, records and traceability. This helps you demonstrate quality and address Non Conformities effectively.
Why choose Bureau Veritas Certification?
Expertise in medical device quality management
ISO 13485 requires a quality management system tailored to the medical device supply chain. We assess organisations involved in design, production, storage, distribution, installation, servicing and related activities.
A single point of contact
Your dedicated contact coordinates planning, audits, certificate issuance and changes. This keeps the process clear, particularly when audits cover documentation, risk management, suppliers, traceability and customer requirements.
Auditors across the Benelux
With offices in Belgium and the Netherlands and a broad network of qualified auditors, we can plan audits efficiently and select an auditor familiar with your sector and organisation. Dutch- or French-speaking auditors are available where required.
Regulatory and supply chain requirements
ISO 13485 addresses legal and customer-specific requirements in the medical device industry. We tailor the certification process to your scope, your role in the supply chain and the relevant quality requirements.
Local knowledge, international reach
For multi-site and international organisations, we can coordinate audits worldwide using local auditors. This supports businesses operating across international medical device supply chains.
Combine certifications efficiently
ISO 13485 can complement standards such as ISO 9001, ISO 14001 and ISO 45001. We can review how to coordinate audits efficiently when you hold several certifications.