Announcing the 2018 SoftwareCPR® public offering of its 62304 and emerging standards impacting Medical Device software and Health IT Course

COURSE DATES: Jan 24 - 26, 2018
COSTS: 3 Full Days for $2,495.00

Combine with multi-student discount of 10% for 3 or more from the same company!

Click below to register now! Registration closes on 1/17/18 at 1:00 pm EST.

Course willl compare and contrast 62304 with FDA expectations!

Course based and framed around 62304 but will address the following aspects as they relate to the 62304 process:

Plus this bonus material:

This 3 day course will be taught by Alan Kusinitz and Brian Pate of SoftwareCPR®. 

Alan was co-chair for AAMI TIR32 Medical Device Software Risk Management,  contributor and reviewer for 80002-1, reviewer for 62304 and was on the committee  that developed SW68 the pre-cursor to 62304.   Brian participated in the development of AAMI TIR32 Medical Device Software Risk Management,  and AAMI TIR45 Effective Application of Agile Practices in the Development of Medical Device Software,  and currently teaches public courses on Software Validation along with FDA  and the use of Agile methods for medical device software.

Both Alan and Brian have provided public and internal FDA training on Software Validation.

Who Should Attend?

For Quality Assurance and Regulatory Affairs professionals this course will also provide a clear understanding of requirements versus areas of flexibility and provide checklists and questions to use for gap analysis, auditing, and vendor and OEM qualification and management. For Product Owners, Scrum Masters/Coaches, software development managers/engineers, risk management, and test engineers this course provides examples, checklists, and partial templates as well as helping in articulation and defense of your approaches to regulatory bodies and internal quality assurance and regulatory affairs departments.

Training Location:

The Domain Hotel in Sunnyvale, CA -- The heart of Silicon Valley!
We suggest calling the hotel to make reservations. Contact Timothy Farr at (408) 260-3604 to reserve your room.
Our group code is: "1801SOFWAR"
Reserve your room now!

More Information:

If you have any interest please reply to this email or call Brian directly at 813-766-0563 or forward this to those you think may be interested.

                    Brian Pate
                    Partner and General Manager