Summary: AAMI, in partnership with Amplifire Healthcare Alliance, is offering new training to correct misconceptions about ISO 13485, ISO 14971, and other standards, using a cognitive science-based platform to enhance learning and retention.

Key Takeaways

  1. AAMI is addressing persistent misconceptions about ISO 13485 and ISO 14971 through specialized training courses.
  2. Partnering with Amplifire, AAMI is using a neuroscience-based platform to enhance rapid learning and retention through cognitive triggers.
  3. The Amplifire platform continuously updates to align with regulatory changes, allowing organizations to track learning progress and address confidently held misconceptions.

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Despite the U.S. FDA’s adoption of ISO 13485 in its Quality Management System Regulation (QMSR), misconceptions about ISO 13485, ISO 14971, and other standards persist, according to the Association for the Advancement of Medical Instrumentation (AAMI). AAMI aims to address these misconceptions through new training on each standard.

To achieve this, AAMI partnered with the Amplifire Healthcare Alliance to create specialized courses for medical device manufacturers, independent service organizations, and healthcare providers. The Amplifire platform, developed by neuroscientists and cognitive experts from Harvard and other institutions, uses cognitive “triggers” to support rapid learning and long-term knowledge retention.

Healthcare Device Training

“I’ve been focused on organizational effectiveness for decades, and this is the first time I’ve felt we have the power to do something radically different and better,” says AAMI’s Chief Learning and Development Officer Robert Burroughs. “This isn’t just about reducing costs or making distribution easier; it’s about leveraging science to do something unimaginable 20 years ago.”

Amplifire CEO Bob Burgin adds, “AAMI is the de facto world leader in driving the safe and effective use of healthcare devices. Their standards are globally recognized in manufacturing, servicing, and healthcare delivery, and their education programs set the quality bar. AAMI members, like those on our Science Board, are thought leaders in their fields.”

Inside the Amplifire Platform

The Amplifire platform uses seven cognitive techniques:

  • Adaptivity: Delivers content tailored to each learner’s needs.
  • Evaluating confidence: Enhances focus and memory.
  • Delayed feedback: Strengthens learning by correcting errors.
  • Gamification: Boosts dopamine levels to sustain engagement.
  • Priming: Prepares the brain to learn new material.
  • Retrieval practice: Reinforces knowledge through recall.
  • Spacing: Increases learning retention with spaced sessions.

Amplifire also identifies and corrects confidently held misinformation, ensuring accurate understanding of standards like ISO 14971 and ISO 13485. The fully online, continuously updated platform aligns with regulatory changes, allowing organizations to monitor individual learning progress and pinpoint areas for improvement.