A famous sports coach once said: “If you are not keeping score, you are just practicing.” The FDA’s Quality System regulation says that manufacturers “shall establish and maintain procedures for… verifying the acceptability of process capability and product characteristics.” Folks, that's asking you to keep score. But regulatory compliance is not the only issue. Any organization that [...]
Cleaning validation of health care products – Requirements for development and validation of a cleaning process for medical devices (ANSI/AAMI ST98) is a new, published standard. It replaces AAMI TIR30 and provides requirements to validate the medical device manufacturer's cleaning processes for processing medical devices. This standard applies to all medical devices that require cleaning before each clinical use of the device. During this training, the design of [...]
For more than three decades, AAMI has hosted the AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation; the premier event for medical device experts who want to be up-to-date on the latest developments, changes, and trends in health technology standards and regulations. This October, the global medical device standards community will come together in-person [...]
A big challenge for Process Validation is to establish objective evidence that a process is capable of consistently delivering quality product. The goal of these two webinars is demonstrate how valid statistical techniques meet this challenge – and better yet, save time, money and resources. The application of valid statistical techniques is encouraged by the [...]
This two-part, four-session series begins with an introduction to AAMI TIR45, Guidance on the Use of AGILE Practices in the Development of Medical Device Software, and then addresses many of the key concepts and recommendations provided by TIR45. With a combination of slides (using Key Takeaways and Diagrams from TIR45) and dialogue with the audience, [...]
Today the news is inundated with stories about cybersecurity compromised businesses, public services, and government operations. Among those we often hear as being compromised are hospitals and healthcare-related organizations. When compromises to healthcare organizations do occur, they have frequently shut down a department’s or an entire organization’s operations so that their ability to deliver healthcare [...]
Regulatory Authorities place the responsibility of the Quality Management System firmly onto the shoulders of a medical device firm’s management team; however, many executives do not have an appreciation or awareness of these requirements. This course presents an overview of the QMS, with a focus on management’s roles and responsibilities to demonstrate an active commitment [...]
While it may not always be the favorite part of a technician’s job, everyone in healthcare technology management (HTM) today has the critical responsibility to enter complete and accurate data into their CMMS. This data is needed to meet regulatory requirements, make smart staffing decisions, ensure the equipment is safe and reliable, protect the hospital [...]
This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International Organization for Standardization (ISO) standards development teams. Participants will learn how to develop and maintain a quality system program that [...]
A Lead Auditor is responsible for leading an audit team in an organization—preparing the audit plan, delivering meetings and submitting audit reports. AAMI’s 2-day Lead Auditor course teaches participants the requirements of and how to utilize ANSI/AAMI/ISO 13485. Join us to gain understanding of best practices of auditing quality managements systems as defined in ANSI/ISO [...]