To the casual observer, Acceptance Sampling Plans can be incredible complex and hard to apply. Worse yet, the subject is a jungle with non-intuitive jargon and crazy acronyms. So why bother? 

The key advantage is that Sampling Plans can save time, money and resources. It certainly answers the question: “How much is enough?”

AAMI is presenting a 2-part webinar on the Risk-Based Computer Software Assurance (CSA) approach for Production, Process and Quality System Software (PPQS) that is detailed in the expected proposed FDA Draft Guidance. This part lecture / part interactive webinar will help you leverage critical thinking to greatly reduce the effort and cost of software validation.

In 2022, Norton Healthcare Corporation's (NHC) Clinical Engineering group achieved the distinction of becoming the first in-house medical device service organization to achieve ISO 13485 accreditation. This milestone was driven by their commitment to establishing a robust Quality Management System (QMS) and aligning with Norton Healthcare Corporate's pursuit of ISO 9001-based accreditation by DNV.

This comprehensive training is specifically designed for HTM leaders, equipping them with the knowledge and strategies needed to achieve regulatory compliance in healthcare technology management (HTM). It covers relevant regulatory agencies, their expectations, and effective strategies for meeting or exceeding compliance standards. By implementing proven strategies, HTM leaders can drive continuous survey readiness, reduce stress levels, and minimize unnecessary work for themselves and their teams.

A significant focus of the training is on alternate equipment management (AEM), a critical aspect of HTM. Participants will gain insights into the specific AEM criteria that regulatory agencies evaluate and receive practical guidance on implementing and documenting AEM effectively. This knowledge empowers HTM leaders to manage alternate equipment, minimize disruptions, and ensure readiness in case of equipment failures or emergencies.

The training aims to empower HTM leaders with the tools and insights necessary to succeed in regulatory compliance. By participating, HTM leaders will gain a thorough understanding of regulatory agencies, their expectations, and effective strategies for achieving and surpassing compliance standards. They will also gain valuable insights into AEM, enabling them to effectively manage alternate equipment and maintain a state of readiness.

The goal of this training is to support HTM leaders in navigating the complexities of regulatory compliance successfully, ultimately enhancing their role in ensuring the safety and reliability of healthcare technology systems.