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ISO 13485

ISO 13485 Training Considerations

The decision to pursue and obtain ISO 13485 Registration is an important step in any organizations maturity. It speaks to the commitment of the organization, its management, and its employees to embrace the world’s most important and widely held medical device quality management system, and therefore realize all the challenges and benefits that it offers. So it follows that garnering the knowledge needed to be successful should be gained through an effective training program offered by an experienced ISO 13485 Training firm. Quality Resource Center offers a full suite of ISO 13485 Training modules that are easily customizable to meet your organizations unique needs

Our ISO 13485 Training Modules can be delivered at our state of the art training center in northern California’s beautiful Silicon Valley and include-

  • ISO 13485 Executive Overview Training

Designed for the busy executive and his or her staff. Quality Resource Center offer 1, 2, and 4 hour versions to help the executive team gain an understanding of the ISO 13485 standard, what it requires, and what it offers to the executive team.

  • ISO 13485 Deployment Team Training

Designed for the Deployment Team. Quality Resource Center offers 4, 8, and 16 hour versions to help the functional team and its managers an understanding of the ISO 13485 standard, what it requires, and what it offers to the organization.

  • ISO 13485 Risk Analysis and Management Training

Risk Management is a critical aspect of ISO 13485 and there are a number of techniques and methods that can be used to address it. But which one is best for your Organization? Quality Resource Center ISO 13485 Risk Analysis and Management Training offers an effective, easy to understand approach to the topic.

  • FDA and CFR 821 Considerations in ISO 13485 –
  • ISO 13485 Regulatory challenges can be overwhelming and it can be hard to know where to begin. Quality Resource Center Food and Drug Administration (FDA) and Code of Federal Regulation (CFR) 821 training helps simplify the task in plain, easy to understand language.
  • ISO 13485 Internal Auditor Training & Certification

Internal Audits are a vital requirement of ISO 13485. Whether you choose to outsource your Internal Audit program to a team of seasoned professionals, or pick up the challenge internally, having a team of successfully trained and certified Internal Auditors will provide invaluable expertise to your organization. Quality Resource Center offers a 16 hour training, testing and certification program that thousands of people have successfully completed since 2003.

In summary, no other firm offers the breadth and scope of ISO 13485 Training programs that Quality Resource Center has been offering for nearly a quarter century.

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If you’re considering ISO 13485 Certification Training for specific modules, or a customized curriculum designed to meet your specific needs, we invite you to contact us for a complimentary consultation Toll Free at (800) 244-5409 or Email Us.