ISO 14971 Training for Medical Device Manufacturers

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Risk management has become increasingly important for medical device companies in the last few years, especially since the implementation of the revised ISO 14971 standard in 2007. BS EN ISO 14971:2009 was released a couple of years later to provides specific requirements related to the Medical Devie Directive (MDD) and the In Vitro Diagnostic Device Directive (VDD). This ISO 14971 training class is conducted by a member of Emergo Group's team of quality and regulatory professionals. Our ISO 14971 training consultants have extensive manufacturing experience and know how ISO 14971:2009 needs to be implemented or integrated with ISO 13485. This ensures that your team will get a high quality training session tailored to the needs of your organization.

Professional, on-site ISO 14971 training for one fixed fee, regardless of how many employees attend.

Our fee for training is based on a set fee plus expenses. This provides a great value for companies that need to train three or more employees at one time. On-site training gives your employees the opportunity to ask questions (something they cannot do with public or online classes) and ensures that every employee is receiving consistent information.

What your team will learn in this ISO 14971 training class:

Overview of the ISO 14971 standard as it applies to medical device companies.
Regulatory and reporting requirements of the standard related to QSR, MDD, IVDD, and others.
Integrating the new standard with ISO 13485 as part of your overall quality management system.
Conducting a review of the intended use of your device.
Modifying your design and development process to incorporate ISO 14971.
Identifying hazards in your product or production process, and estimating their severity.
Judging the probability that harm may occur from those hazards.
How to control those risks and monitor the effectiveness of the controls put in place.

OPTIONAL: This ISO 14971 training class can be extended to two or more days depending on how in-depth you want us to cover the subject.