Tag

iso
Having trouble keeping up with standards activity? You are not alone!  The pace of new and emerging standards creates a challenge for even the most organized and well staffed software and quality assurance teams.  Whether it is digital health, risk management, software process, usability, or the ever challenging cybersecurity, being aware and understanding upcoming changes...
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This content is only available to our Premium subscribers. See our Subscribe page for information on subscriptions. Raffaele Caliri and Jordan Pate have recently updated our 62366-1 Assessment Checklist to align with the 2020 amendment.  This version of the standard has been pared down a bit and looks a lot different than the familiar 2008 version...
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There is a new draft for vote of ISO 13485 Medical Devices – Quality Management systems – requirements for regulatory purposes. This version updates the references to ISO 9001 to the 2008 version. Some new requirements include: A requirement for a risk management process has been added in the product realization phase and ISO 14971...
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This content is only available to Standards Navigators subscribers.  See our Subscribe page for information on subscriptions. The link provides the response from ISO TC 210 to the EC objections to ISO 14971.  ISO TC210 Comments on deharmonization of EN14971
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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 training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

TBD

 


 

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: TBD

 


 

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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