November 3, 2021
Company: MEDTECH SAS Date of Enforcement Report: 11/3/2021 Class I PRODUCT ROSA One 3.1 Brain application: The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries. Recall Number: Z-0118-2022 REASON The firm has...
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Company: AB SCIEX Date of Enforcement Report: 11/3/2021 Class II PRODUCT Cliquid MD (Version 3.4) software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288 Recall Number: Z-0175-2022 REASON The values of the Internal Standard (IS) concentrations are incorrectly derived when the...
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Company: Xstrahl Limited Date of Enforcement Report: 11/3/2021 Class II PRODUCT Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy – 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy – 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 – 225kV Superficial / Orthovoltage X-Ray Therapy System; (4) Xstrahl...
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Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Content of Premarket Submissions for Device Software Functions. The draft guidance is intended to reflect FDA’s most current thinking on the recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, including both...
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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

Email to request a special pre-registration discount.  Limited number of pre-registration coupons.

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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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