Risk management has become increasingly important for medical device companies in the last few years. ISO 14971:2012 was released to provide specific requirements related to the Medical Devices Directive (MDD), Active Implantable Medical Device Directive (AIMD), and the In Vitro Diagnostic Device Directive (IVDD).
This ISO 14971 training class is conducted by a member of Emergo's team of quality and regulatory professionals. Our ISO 14971 training consultants have extensive manufacturing experience and know how the standard 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 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, AIMD, IVDD, and other regulatory requirements.
- 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 14971 training can be extended to two or more days depending on how in-depth you want us to cover the subject.
Please contact us if you are interested in group ISO 14971 training for your company.