Tag

ivd
In February 2022, the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745, released revision 1 of MDCG 2021-21, Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices.  You can view the copy at this link: MDCG 2021-21 Rev.1 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical...
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US FDA has proposed a new rule to exempt Cytometry instruments used for counting or characterizing cells (a well-understood and mature technology), from premarket notification requirements.  Cytometry instruments used for sorting or collecting cells, and instruments that are used as an automated hematology analyzer, or that perform automated differential cell counts, will still require premarket...
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Company: Ortho-Clinical Diagnostics Date of Enforcement Report: 12/20/18 Class II PRODUCT VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid. Recall Number: Z-0651-2019...
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Company: Ortho-Clinical Diagnostics Date of Enforcement Report: 12/20/18 Class II PRODUCT VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Recall Number:...
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Company: Philips Electronics North America Corporation Date of Enforcement Report: 12/14/2018 Class II PRODUCT Xper Flex Cardio Physiomonitoring System Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081 Recall Number: Z-0614-2019 REASON There are 3 issues: Under certain conditions, real time waveforms may not be accurately plotted or displayed. The...
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM418205.pdf
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Draft of the revised IVDD is at the link provided. EU Proposed New IVD
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For devices where the medical device manufacturer intends to maintain remote access capability for service and updates, controls are needed to ensure this access does not compromise the security or operation of the device. There is one FDA recognized standard that addresses this for clinical laboratory devices, but many of the provisions could be instructive...
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SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

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. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

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

Instructor: Brian Pate

Next public offering:  TBD

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

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Medical Device Cybersecurity (Public or Private)

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. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

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

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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