Evidence-based

Instructional Labeling and Training

Reduced use-errors for first time users by up to 90%.

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evidence-based-instructional-design

regulatory-guidance

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Evidence-based Instructional Labeling and Training

The Agilis proprietary, evidence-based instructional design process has proven to produce more effective labeling (IFU) and training in less time than other traditional methods. Our professional instructional designers are up to date on the latest innovations in information design and electronic delivery. We have an understanding of the real world needs of professional and lay users in clinical and home healthcare environments. Both FDA and AAMI seek out our expertise in instructional design. Our services include:

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  • Assessment of readiness for pre-summative and summative human factors testing
  • User guides and quick reference guides
  • Multi-media including video and web
  • Diagnostic assessments to improve clients’ existing labeling and training
  • Expert guidance on FDA standards and guidelines
  • Product launch training plans for users and key stakeholders
  • Customized workshops
  • Consulting to improve your internal instructional labeling processes

Results

Clients who receive our Instructional Labeling & Training services achieve:

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  • Reduced iterative testing to prepare for summative validation
  • Demonstrated success with developing instructional materials for low literacy users
  • Reduced time needed to deliver training by up to 70%
  • Reduced use-errors for first time users by up to 90%
  • Lower post-market support costs by up to 60%
  • Instruction that complies with FDA guidelines and supports safe user performance satisfaction

Human Factors Experts

The Agilis process prepares our clients to answer Regulatory’s most fundamental bottom line question: “Show us the body of evidence that provides a compelling, comprehensive and valid case that your device and IFU support safe and accurate user performance.”