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AAMI Event In Person and Virtual – Design Control Requirements – Integrating the Quality System Regulation – November 30 to December 2, 2022

This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience. Program Objective  Upon completing this [...]

2022-11-17T21:58:44+00:00November 17th, 2022|

AAMI Event – Sampling Plans-Made Easy – November 16 and 17, 2022

Event Overview To the casual observer, 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?” Sampling [...]

2022-11-10T21:22:41+00:00November 10th, 2022|

AAMI Event / Keeping Score – Measuring Product and Process Capability – October 26, 2022

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 [...]

2022-10-19T20:01:28+00:00October 19th, 2022|

AAMI Key Updates: AAMI/ANSI ST98 (October 2022) – October 25-27, 2022

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 [...]

2022-10-19T19:58:02+00:00October 19th, 2022|

AAMI Event – 2022 International Conference on Medical Device Standards and Regulations – October 17-19, 2022

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 [...]

2022-10-11T19:58:11+00:00October 11th, 2022|

AAMI Online Event – Valid Statistical Procedures for Process Validation – Made Easy – September 28-29, 2022

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 [...]

2022-09-26T22:26:00+00:00September 26th, 2022|

AAMI – Understanding TIR45: Agile Methods for Medical Device Development – September 21, 23, 29, and 30, 2022 – 1:00 pm – 3:00 pm ET

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, [...]

2022-09-19T21:06:10+00:00September 19th, 2022|

AAMI Virtual Course – Medical Device Cybersecurity 101 for HTM Professionals – September 13-15, 2022

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 [...]

2022-09-13T20:50:39+00:00September 13th, 2022|

AAMI Online Course – Quality Management System Highlights for Management – September 12-15, 2022

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 [...]

2022-09-13T20:48:06+00:00September 13th, 2022|