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upcomingtraining

Upcoming Training

Oriented for Central European Time! Registration now for our next “Being Agile and Yet Compliant” Training Course.  Our fall offering is coming up.  Conveniently scheduled to work across many timezones! COURSE DATES: March 7 & 28, 2024 HOURS: TRAINING LOCATION: Virtual – live online COST: 4 half days for $1,920 per person Special discounts available...
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62304 Public Training Course Course Dates:  June 5-7, 2024 CANCELLED COST: 3 Full Days for $2,900.00 (50% refundable through January 31, 2024. Fully transferable at any time.) Limited number of Early Bird discount coupons (worth $895)  available on a first come-first serve basis.  Use coupon code: (thats three-zero-letter p-letter e-letter r) Early bird discount available...
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Registration now for our next “Being Agile and Yet Compliant” Training Course.  Our fall offering is coming up.  Conveniently scheduled to work across many timezones! COURSE DATES: December 12-15, 2022 (16 hours of training) HOURS:  11 am until 3 pm EDT each day TRAINING LOCATION: Virtual – live online COST: 4 half days for $1,920...
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ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective Public Training Course DATES:  Jan 9-11, 2023 Includes “how to” for application of IEC 62304 for software risk management! COST: 3 Full Days for $2,995 DISCOUNTS: 3 or more students from same company: 10% discount (off full registration) November 2022 Early Registration:  $2,395 Register at...
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IEC 62304 and Emerging Standards for Medical Device and Health IT Software DATES:  June 6-10, 2022 (New date) Clock time each day:  10 am – 3 pm US EDT (one hour break from 12:00 pm to 1:00 pm US Eastern time) COST: 5 short days for $2,200.00 – Multi-student discount available for 3 or more students...
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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: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

Register Now

 


 

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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