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So far Teresa Cain has created 162 blog entries.

AAMI Virtual Event: Design Control Requirements – Integrating the Quality System Regulation – February 12-14, 2024

This intensive 3-day, hybrid (in-person or virtual) 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. For more information:  https://aami.my.site.com/s/lt-event?id=a1Y4U00000JuRLL

2024-02-01T22:35:38+00:00February 1st, 2024|

AAMI Event – Medical Device Software Validation – November 7-9, 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 [...]

2023-10-18T20:14:17+00:00October 18th, 2023|

AAMI Virtual Event: Integrating Risk Management into the Product Life Cycle – October 3-5, 2023

This course will cover risk management principles used throughout the lifecycle of a product (design, manufacturing, post-production, and retirement). Instructors will also identify linkages between risk management processes and quality system processes. Participants will discover how to use regulatory databases to support risk management activities at different stages of the product lifecycle, as well as [...]

2023-09-15T21:20:43+00:00September 15th, 2023|

AAMI Virtual Event – Design Control Requirements – Integrating the Quality System Regulation – September 12-14, 2023

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 [...]

2023-08-22T18:35:28+00:00August 22nd, 2023|

AAMI Event – Process Validation Requirements & Industry Practices – August 7-9, 2023

This 3-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System Regulation and recognized process validation guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. Topics include planning, protocol development, validation execution, monitoring & control and re-validation to meet [...]

2023-07-25T21:58:49+00:00July 25th, 2023|

AAMI Virtual Course – Design Control Requirements – Integrating the Quality System Regulation – July 17-19, 2023

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. For more information:  https://aami.my.site.com/s/lt-event?id=a1Y4U00000KEZvs

2023-07-17T21:02:58+00:00July 17th, 2023|

AAMI Online Course: Risk-Based Computer Software Assurance Approach for PPQS – July 11th and July 13th from 1:00 pm to 3:00 pm EST

This course is designed for software developers, quality engineers, auditors, process engineers, manufacturing engineers, quality assurance and regulatory compliance personnel, or others involved in the use of Production Process and Quality System Software and responsible for meeting industry standards and FDA requirements. https://aami.my.site.com/s/lt-event?id=a1Y4U00000J1xRE

2023-06-13T21:36:09+00:00June 13th, 2023|

AAMI Virtual Event: Medical Device Software Validation – May 31 – June 2, 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 [...]

2023-05-25T20:34:12+00:00May 25th, 2023|

AAMI Online Event – Medical Device Software Validation – May 23, 2023 & May 25, 2023 / 1:00 pm to 3:30 pm ET

The regulatory pace of change is accelerating for the in-vitro diagnostics (IVD) industry. Evolving regulatory standards impact IVD manufacturers, central laboratories, contract research organizations and manufacturers who bring new IVD devices to the commercial market or sponsor drug or medical device clinical trials that utilize IVD products as part of trial conduct. The In-Vitro Diagnostic [...]

2023-05-19T20:34:46+00:00May 19th, 2023|

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|