ISO 13485 Training

Quality Resource Center (QRC) offers a full suite of ISO 13485 training modules for medical device organizations, each one customizable to your products, processes, and certification timeline.

ISO 13485 is the world’s most widely held medical device quality management system standard, and it is now referenced directly by the FDA’s Quality Management System Regulation. Registration is a real commitment from management and staff alike, so the knowledge behind it should come from a firm that has implemented these systems, not just taught them.

Call (800) 244-5409 or request a consultation.

ISO 13485 Training Modules

Courses are delivered at QRC’s training center in Silicon Valley, onsite at your facility, or by live webinar.

ISO 13485 Executive Overview Training. For the busy executive and his or her staff, in 1, 2, and 4 hour versions, covering what the standard requires and what it offers the leadership team.
ISO 13485 Deployment Team Training. For the implementation team and its managers, in 4, 8, and 16 hour versions, covering the standard clause by clause and what each requirement means in practice.
ISO 13485 Risk Analysis and Management Training. Risk management is central to ISO 13485, and several methods can satisfy it. This module gives your team a clear, practical approach to ISO 14971 risk management, design and process FMEA, and the link between risk files and production controls.
FDA and CFR Considerations in ISO 13485. Regulatory expectations are hard to approach cold. This module explains FDA device requirements and how they relate to your ISO 13485 system, in plain language.
ISO 13485 Internal Auditor Training & Certification. Internal audits are a requirement of the standard. QRC’s 16 hour training, testing, and certification program has been completed by thousands of people since 2003, whether your audit program runs in house or is outsourced.
Management Representative Training. For the person who will own the quality system day to day and face the registrar.

Training or Implementation?

Training gives your team the knowledge to run a system. If you also need the system itself built, documented, and taken through a registrar audit, see our ISO 13485 consulting services. Many device companies combine the two: QRC implements the quality management system while training the people who will maintain it. Our practical guide to ISO 13485 covers what the standard asks of a device company before you commit budget to either.

Request a Quote

If you are considering specific ISO 13485 training modules, or a customized curriculum designed around your organization, we offer a complimentary consultation.

Call (800) 244-5409 — local (408) 371-9995 — or request a consultation.