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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|

Virtual AAMI Event – HTMLive! BMET Educators Share How to Teach Proper CMMS Date Entry – September 6, 2022, 2:00 to 3:00 pm ET

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 [...]

2022-08-22T19:57:27+00:00August 22nd, 2022|

AAMI Event – Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485 – August 22, 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 [...]

2022-08-08T21:10:12+00:00August 8th, 2022|

AAMI Virtual Event – Lead Auditor for Management Systems & Processes – Principles & Practices – August 4-5, 2022

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 [...]

2022-08-03T21:45:02+00:00August 3rd, 2022|

AAMI Event: Test Method Validation Workshop – July 19-20, 2022

Test Method Validation (TMV) is not only an FDA regulatory requirement, it is key to quality and financial success for a firm. How do you know that you have quality if you cannot measure? This subject has been called many names, such as Measurement System Analysis (MSA) and Gauge Repeatability & Reproducibility (GR&R). There is [...]

2022-07-14T19:57:02+00:00July 14th, 2022|

AAMI Virtual Event – Corrective & Preventive Action Requirement & Industry Practice – June 27-28, 2022

This 2-day course provides intensive coverage of the elements of a corrective and preventive action (CAPA) system. Some primary topics include: the purpose of a CAPA system and how it is integrated throughout a Quality Management System; appropriate data sources and how to coordinate, analyze and manage them; methods for verifying and / or validating actions; [...]

2022-06-16T21:11:09+00:00June 16th, 2022|

AAMI Course – Medical Device Cybersecurity 101 for HTM Professionals (Exchange 2022) – June 3, 2022 in San Antonio, TX

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 [...]

2022-05-23T19:43:23+00:00May 23rd, 2022|

AAMI Virtual Course – Industrial Sterilization for Medical Devices – May 10-13, 2022

Industrial Sterilization for Medical Devices is a comprehensive 4-day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.  Participants will learn how to apply the principles of sterilization and address requirements during product design. Participants will also determine how [...]

2022-04-27T20:52:10+00:00April 27th, 2022|

AAMI Virtual Course – Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485 – April 18-22, 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 [...]

2022-04-19T21:24:24+00:00April 19th, 2022|