2023 SoftwareCPR Public Training Course - ISO 14971 Medical Device Risk Management, A Software Organization’s Perspective

Monday, 9 January 2023 8:00 AM - 5:00 PM EST

124 S. Franklin St, Tampa, FL, 33602, United States

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Full Registration (multi-student discounts) Partial Approval - $2,995.00

Sales end on 01/06/2023

Course registration for 3 day training in ISO 14971 Risk Management - Software Emphasis. Save 10% when 3 or more register from same company. Fully refundable through November 30, 2022 (course registration fee only).

December Discounted Registration Partial Approval - $2,495.00

Sales end on 12/31/2022

Per person cost during December 2022. No refunds, but substitutions are allowed after purchase. This discount does not combine with other discounts.

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Walk Up Registration Partial Approval - $3,295.00

Not on sale until 01/06/2023

Day of event walkup registration. No refunds. No discounts.

SRT-01 Partial Approval - $1,995.00

Sales end on 12/26/2022

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Monday, 9 January 2023 8:00 AM - 5:00 PM EST

Center for Advanced Medical Learning and Simulation, 124 S. Franklin St, Tampa, FL, 33602, United States.

Our risk management course focuses on the software risk management process based on ISO 14971 device as an input, IEC 62304 risk management requirements, and guidance for software found in IEC/TR 80002-1, both which are consensus standards with US FDA.

As with all SoftwareCPR® courses, our approach is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Our training covers regulatory, quality, and the details of the software development process necessary for compliance.

Our standard format course covers the topics listed below:

§ Brief Regulatory Background – US FDA, EU
§ SOUP, OTSS, and Legacy Software
§ 62304 Safety Classifications vs. FDA LOC
§ Harms – Direct & Indirect, Hazards, Hazardous Situations
§ System, Device, Product level considerations – 60601-1, 82304

§ Identifying Causes and Causal Pathways, Failure Modes

§ Probability and Severity related to software

§ Risk Control – Design, Architecture
§ Risk Control Effectiveness
§ Verification and testing

§ Managing Risk after release
§ Risk Control - Process
§ Documentation, Traceability, Electronic records
§ Tailored Cybersecurity vulnerability analysis, cyber controls, validation § Use Error and Human Factors Engineering 

 

Workshops and exercises integrated throughout teaching modules.

Email brian@softwarecpr.com for more information.

Dates:

  • Jan 9-11, 2023 in Tampa, FL
  • 3 days, 8:00 am to 5:00 pm EDT each day

Location:

  • CAMLS - Center For Advanced Medical Learning And Simulation
    124 South Franklin Street | Tampa, Florida 33602

Instructors:

  • Brian Pate - Partner and General Manager at SoftwareCPR®
  • Dr Peter Rech - Partner at SoftwareCPR®

SoftwareCPR Credentials:

Brian Pate taught the AAMI/FDA course on Software Regulation to FDA Reviewers publicly in DC for over 10 years and has taught the course at FDA.  Brian served on the TIR working group that created the AAMI TIR32-2008 (later became IEC/TR 80002-1) for software risk management, and TIR45-2012 Guidance on the use of Agile practices in the development of medical device software and is a reviewer for the 2nd edition of TIR45.  Brian currently serves as faculty for the AAMI/FDA Compliant Use of Agile Methods public course and also has served as an instructor for the AAMI Design Controls course.  Brian is a member of the Underwriters’ Laboratories (UL) Standards Technical Panel 5500, Remote Software Updates.

Dr Peter Rech has over 20 years’ experience in systems and safety engineering in regulated industries in individual contributor and management roles.  He has worked with Class II and III medical devices including implantable pacemakers, infusion pumps, and remote monitoring devices and apps.  He held certificates as INCOSE Certified Systems Engineering Professional and TUV Rheinland Certified Functional Safety Engineer. He holds a Doctor of Philosophy (PhD), Physical Chemistry, Free University Berlin, and speaks English, German,  and French.

Cancellation policy

Early Bird Registration:  No refunds.

Full Registration:  Fully refundable through November 30, 2022 (course registration fee only).

September and October 2022 Registration:  50% refund if cancelled prior to Nov 30, 2022 (course registration fee only).  Substitutions are allowed after purchase.

November and December 2022 Registration:  No refunds, but substitutions are allowed after purchase.

 

Crisis Prevention and Recovery LLC (SoftwareCPR)

https://www.softwarecpr.com

SoftwareCPR® provides full service regulatory compliance and premarket submissions support for Medical Device Manufacturers including quality systems development, risk management - including for Health IT and Standalone Software, Human Factors and usability engineering, as well as hands-on validation services for Pharmaceutical and Medical Device companies. We also have extensive experience related to FDA enforcement action representation and negotiation and have served as expert witnesses.

Contact the Organizer

Peter Rech
Partner
SoftwareCPR

About Peter Rech

Partner
SoftwareCPR
Brian Pate
Partner and General Manager
SoftwareCPR

Brian has provided training internally for FDA and was on the working groups for TIR32 (IEC/TR 80002-1) and TIR45.

http://www.softwarecpr.com

About Brian Pate

Partner and General Manager
SoftwareCPR