02
Nov
2022

14971 Risk Management Training Course

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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 this EventZilla link:  https://events.eventzilla.net/e/2023-softwarecpr-public-training-course–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610

Come to sunny Tampa, Florida in January 2023 for our newly updated “ISO 14971 Medical Device Risk Management, A Software Organization’s Perspective” 3-day training course.

This course takes a deep dive into ISO 14971:2019 so that people responsible for SaMD can develop and deepen their understanding of the device level, or product level, risk management requirements. We have found over the years that many of our clients struggled with software risk management because they did not fully embrace device level risk management. This course gives the students a full understanding of ISO 14971 and then explains how cybersecurity, usability, and software risk analyses feed into the device level risk analysis. The course follows the typical process (or processes) introduced by ISO 14971 and IEC 62304, and integrates IEC/TR 80002-1 as a valuable resource for software risk management.

Course Modules

  • Regulatory and Standards Background
  • Intended use / harm
  • System Level Hazard Analysis
  • Detailed Risk Analysis Methods
  • Use Error Hazard Analysis
  • Cybersecurity Threat Analysis
  • Software Hazard Analysis
  • Risk Estimation
  • Risk Control
  • Risk Evaluation and Residual Risk
  • Production and Post Market Risk Management
  • Planning & Documentation

Who Should Attend?

  • System Engineering
  • Safety/Risk
  • Cybersecurity
  • Software Engineering
  • Ux
  • Quality Assurance
  • Regulatory Affairs
  • Product Owners
  • Scrum Masters/Coaches
  • Software development management
  • Production/DevOps
  • Test management/engineering

This 3 day course will be taught by Brian Pate of SoftwareCPR and Dr Peter Rech of SoftwareCPR.  You can download credentials sheets on our Meet Our Team page (https://www.softwarecpr.com/consultation/).

Full credentials on our website: www.softwarecpr.com

Training Course Location

Center for Advanced Medical Learning and Simulation (CAMLS)

124 S Franklin St, Tampa, FL 33602

https://camls-us.org/

Downtown Tampa is convenient for walking or using water taxi (https://www.piratewatertaxi.com) or trolley (http://www.tecolinestreetcar.org).

A trip to Tampa must include all the many great restaurants.

Highly recommend Bern’s (https://bernssteakhouse.com)

More than 117 years of history at the beautiful and authentic Columbia (https://www.columbiarestaurant.com/ybor-city-tampa)

Ulele “celebrates the vibrant fusion of ingredients from Florida waters and land once home to many Native American.”(https://ulele.com/#banner)

Cena is a modern, fresh and simple Italian food served in a contemporary and stylish setting. ( https://cenatampa.com )

Oak and Ola, located in the newly renovated, historic Armatureworks, is a stand-alone restaurant featuring the culinary stylings of James Beard Award-Winning Chef Anne Kearney. (https://www.oakandola.com/home)

Partner Hotel

The Hyatt Place/Hyatt House in downtown Tampa is conveniently located just 0.3 miles from CAMLS.  The Hyatt “infuses its modern chic designs with Tampa’s rich Latin History.”  Enjoy stunning city views from the outdoor swimming pool located on the 5th floor deck or start your day with a workout session on one of the Peloton Bikes in the Fitness Center.  Many excellent restaurants are located within easy walking distance, or by trolley or water taxi.  Several onsite restaurant/beverage venues include the Corazon Bar/Restaurant, Wicked Pour Tap House, Junmai Station Sushi, and a full Starbucks Café on premises.

You can obtain special CAMLS Hyatt hotel pricing at this website:

https://camls-us.org/booking-information/partner-hotels/hyatt/

Still Not Sure?  Need more Info?

Contact us using this form:

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

SoftwareCPR Training Courses:

Being Agile & Yet Compliant (Public)

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

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

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offering: Dec 3, 4, & 5, 2024 – 12:00 pm to 5:00 pm CET

Register Now

 

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

Call or email now to schedule a private, in-house class. The fall schedule is filling up!

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

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

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
office@softwarecpr.com
Partners located in the US (CA, FL, MA, MN, TX) and Canada.