
Creates detailed functional and technical design documents, test plans and implementation documents.Configuring the Kronos WFC application for payroll Configuring Accrual Interface and balance issues, Configuring and monitors Kronos 4500 and InTouch clocks for Kronos app v.8.0.3 Installing server updates, Modifying SQL queries and interfaces for reporting purposes.I have a willingness to learn new methods and new tools, and I can easily and quickly meets all the expectation of the position and consistently makes contributions well beyond the demands of the job.I would love to have a position that will use my skills to reach future goals that would benefit myself as well as the company.Detail oriented excellent interpersonal, communication and organizational skills. 9 years in healthcare IS field, 8 years in PACS Administrative skills and accounts payable.Over 17 years in IT operations and Kronos applications development, including 12 years in computer technical support and 10 years in customer service.Special deep discount pricing available to FDA attendees and other regulators. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations.
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IEC 62304 and other emerging standards for Medical Device and HealthIT Software (Public or Private) Instructor: Dr Peter Rech, 2nd instructor (optional)
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The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 8, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies. Overall approach will be tied to relevant standards and FDA guidance documentation. This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Medical Device Cybersecurity (Public or Private)

Incremental and iterative software development lifecycle managementĢ-days onsite with group exercises, quizzes, examples, Q&A.Agile principles that align well with medical.Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!
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How to perform software hazards analysis.ģ-days onsite with group exercises, quizzes, examples, Q&A.īeing Agile & Yet Compliant (Public or Private).


Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective training course is now open for scheduling! Ge Healthcare IT, Barrington, IL on Voluntary: Firm Initiated recall is ongoing. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.Ī software defect was discovered that causes images to be out of context with clinical information.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Data and images are acquired through DICOM compliant imaging devices and modalities. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment.
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Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
