Bureau Veritas

ISO 13485 certification for medical device quality management systems with Bureau Veritas in North America

Medical device quality management

ISO 13485 Certification for Medical Device Quality Management Systems

Organizations operating within the medical device industry work in an environment where consistent processes, product quality and effective control of the quality management system are essential. ISO 13485:2016 provides an internationally recognized framework developed specifically for the medical device industry.

The standard can apply to organizations involved in one or more stages of the medical device lifecycle, including design and development, production, storage and distribution, installation, servicing, technical support, and final decommissioning and disposal.

Its requirements may also be applied by suppliers and external providers that provide raw materials, components, subassemblies, sterilization, calibration, maintenance, distribution or other services to medical device organizations.

Bureau Veritas is recognized as an accredited ISO 13485 certification body providing independent third-party certification and audit services for medical device manufacturers, suppliers and service providers.

Speak with a Certification Expert

Why Choose Bureau Veritas

✓ Accredited certification body recognized globally for ISO 13485
✓ Expert auditors with deep medical device industry experience
✓ Global reach with local expertise to support international expansion

Why organizations choose ISO 13485

Benefits of ISO 13485 Certification

ISO 13485 provides a recognized framework for managing quality across medical device operations. Certification can help your organization:

Help meet quality and regulatory requirements

ISO 13485 helps organizations define their role in the medical device supply chain and establish a quality management system that addresses the regulatory requirements applicable to their activities.

Use a process-based approach

ISO 13485 helps organizations identify, connect and manage related processes as one system, supporting consistent controls, clear responsibilities and effective outcomes.

Promote industry consistency

Standardized quality management system requirements support more consistent practices and clearer communication across the medical device industry and related services.

Strengthen stakeholder confidence

Independent certification demonstrates that the quality management system has been assessed against the recognized ISO 13485 standard, strengthening confidence among customers, suppliers and other stakeholders.

During the ISO 13485 certification audit: Bureau Veritas evaluates the medical device quality management system against the requirements applicable to the organization's activities and defined certification scope. Identified nonconformities must be addressed before certification can be granted or maintained.

Common questions

Frequently Asked Questions

Learn more about ISO 13485 certification, including the standard, typical timing, cost considerations and the certification cycle.

ISO 13485:2016 is the international quality management system standard for medical devices and related services. It emphasizes consistent processes, risk management, documented controls and applicable requirements throughout the device lifecycle. Third-party certification confirms that the quality management system has been independently assessed against the standard within a defined certification scope.
The timeline depends on factors such as the certification scope, number of sites, workforce size, product and process complexity, and readiness for audit. It also depends on how quickly any identified nonconformities are corrected and accepted. Bureau Veritas confirms the audit duration and certification process after reviewing the organization's information.
Certification costs vary according to factors such as employee count, certification scope, number of locations, operational complexity and required audit time. Bureau Veritas prepares a proposal after collecting the information needed to determine the appropriate audit program.
Accredited management system certification generally operates on a three-year cycle, with surveillance audits between the initial certification and recertification audits. Bureau Veritas confirms the specific audit program and timing for the organization. The audit program must be maintained for the certificate to remain valid.

Ready to discuss certification?

Start Your ISO 13485 Certification Process

Whether you are pursuing initial medical device certification or transferring an existing ISO 13485 certificate, Bureau Veritas North America can help you understand and determine the appropriate next steps.

Complete the form above or contact Fred Brown directly.

Fred Brown Sales Director

720-246-8263
fred.brown@bureauveritas.com