Training Events

24

JAN

2018

26

JAN

2018

62304, FDA, and Emerging Standards for Medical Device and HealthIT

The Domain Hotel, Sunnyvale, CA

This 3-day course is framed around 62304 and covers all process requirements for medical device, HealthIT, and medical mobile app software. Learn FDA and US regulations and how they align with 62304, and other key standards such as 82304, 80002-1, and 62366. Topics will include the use of agile methods, cybersecurity aspects, usability, and software risk analysis.

Course taught by Alan Kusinitz - Founding Partner at SoftwareCPR® and Brian Pate - Partner and General Manager at SoftwareCPR®.

19

MAR

2018

21

MAR

2018

Regulatory Requirements for Software Validation in the Medical Industry

Arlington, VA

15

OCT

2018

16

OCT

2018

Effective Application of Agile Practices in the Development of Medical Device Software

Las Vegas, NV

Instructors for internal FDA software validation training and lead instructors for public AAMI/FDA Software Regulation Training courses, Alan Kusinitz, SoftwareCPR®’s Founder, and Brian Pate develop and coordinate SoftwareCPR® training courses on the Quality System Regulation, Design Control, Software Regulation and international medical device, Usability, and HealthIT Standards.

Our instructors understand regulatory agency expectations and can train your staff accordingly and coach them on how best to articulate and defend your approaches in FDA terms.

Our instructors have been in involved in software standards development including IEC 62304, AAMI SW68, AAMI TIR32, IEC 60601-1 PEMS, UL 1998, IEC 80001, AAMI TIR45, and IEC 80002 and can train your staff in pragmatic and efficient methods of conformance to standards.

Our training is tailored to your needs, your products, your regulatory perspective, and your business objectives.

Our training includes FDA enforcement examples, key FDA guidance, electronic, checklists, and other educational aides.

We offer both awareness and skills training. Awareness training courses provide short overviews of key concepts and requirements ranging from 2 hour executive overviews to one day introductory courses. Skills training courses are generally multi-day and are highly interactive using short exercises, formal workshops, and free form and structured instructional Q&A.

Fully customized courses integrating customer policies and procedures are prepared on request and can be integrated into internal company training programs or produced as self-study computer-based training modules.

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T: (813) 766-0563