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So far Teresa Cain has created 153 blog entries.

AAMI Virtual Event – Human Factors for Medical Devices – March 14-16, 2023

Medical device manufacturers with robust human factors processes are leading the market, proving to have better clinical outcomes and better quality. Attend AAMI’s three-day Human Factors for Medical Devices training to understand critical human factors processes to consider when designing a medical device, how they affect its safety, and which steps to take to mitigate [...]

2023-03-07T22:09:28+00:00March 7th, 2023|

AAMI Virtual Event – Medical Device Software Validation – March 21-23, 2023

During this 3-day training, learn how to develop and validate medical device software in an ever-changing landscape of regulations and technology. This class will ground you in all the relevant regulations, standards and guidance and help you understand how risk, cybersecurity, cloud computing and mobile apps impact the medical device software space.  It will also [...]

2023-02-28T21:30:39+00:00February 28th, 2023|

AAMI Event: Integrating Risk Management to the Product Life Cycle – February 1 – 3, 2023

This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA, ANSI/AAMI/ISO 14971 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors [...]

2023-01-26T22:37:56+00:00January 26th, 2023|

AAMI Event: Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485 – December 12 – 16, 2022

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 [...]

2022-12-09T21:24:30+00:00December 9th, 2022|

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|