February 8, 2017
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 2/8/2017 Class lI: PRODUCT Syngo.plaza, picture archiving and communications system. Recall Number Z-1116-2017 REASON Software update for improvements and to resolve several issues RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 1/11/2017 Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 2/8/2017 Class lI: PRODUCT Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation....
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Company: Mevion Medical Systems, Inc.. Date of Enforcement Report 2/8/2017 Class lI: PRODUCT MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy Recall Number Z-1122-2017 REASON An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened RECALLING FIRM/MANUFACTURER Mevion Medical Systems, Inc., Littleton, MA on...
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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

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