October 15, 2018
FDA announces a new pilot program to simplify certain 510(k)s. For more information on eligibility click the link and scroll to near the bottom of the page.  
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Company: GE Medical Systems, LLC Date of Enforcement Report 8/24/2018 Class II: PRODUCT GE Healthcare MRI Systems, Software Version 11.x Recall Number: Z-0110-2019 REASON The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch. RECALLING...
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Underwriters Laboratories, Inc. published the First Edition of the Standard for Safety for Remote Software Updates, UL 5500 on September 6, 2018. This standard covers remote software updates, accounting for the manufacturer’s recommended process to ensure safety. It is limited to software elements having an influence on safety and compliance with the particular end product...
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This final guidance, “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices,” replaces the 2013 draft guidance. This guidance focuses on clarifying and formalizing existing FDA practice including the requirement to submit FDA’s standards form for each standard used as well as discusses the use of obsolete standards. Originally standards were a...
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Upcoming SoftwareCPR Training Courses:

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.

Instructors: Dr. Peter Rech, Brian Pate

Discount Registration through October 31, 2022.  Reserve your spot!

Register here:–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610


Public Course – Dec 12-15, 2022 – Being Agile & Yet Compliant (virtual)

COST: 4 half days for $1,920 per person

HOURS: 11 am until 3 pm EDT each day

TRAINING LOCATION: Virtual – live online

Register here:


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