Day

October 1, 2018
For more information on eligibility click the link. You can also download the current working model.
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Company: Varian Medical SystemsDate of Enforcement Report 10/10/2018 Class lI: PRODUCT VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. Recall Number: Z-0005-2019 REASON Reports have been received of...
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Company: Varian Medical SystemsDate of Enforcement Report 10/3/2018 Class lI: PRODUCT TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated....
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Vancouver, BC Canada . Focused on global regulatory affairs and harmonization. For more information click the link provided. RAPS Regulatory Convergence
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October is National Cybersecurity Month; for more information from FDA click the link.
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Information on the FDA CDRH Patient Engagement Advisory Committee, including how to nominate candidates.
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FDA Center for Biologics provides manufacturers with technical assistance. For email and phone contact information, and other information about this service, click the link.
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Company: Radiometer America Inc.Date of Enforcement Report 10/3/2018 Class lI: PRODUCT ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or...
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Upcoming SoftwareCPR Training Courses:

Public Course – Oct 18-21, 2022 – Being Agile & Yet Compliant (virtual)

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/october-2022-softwarecpr-agile-and-compliant-training-course-2138573767

 

Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/2023-softwarecpr-public-training-course–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610

 

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