Training for the Medical Device Industry
Medical device software needs to be developed in compliance with FDA regulations including:- FDA Quality Management System Regulation (QMSR)
- FDA Guidance Documents
- EU Regulations: MDR and IVDR
- Standards: ISO-13485, ISO-14971, IEC-62304, IEC-62366-1,
- Standards: ANSI AAMI SW96 and AAMI TIR 57
The training courses I offer can help your staff understand and interpret the regulations, FDA Guidance documents, and international standards from a software perspective and in a manner that is consistent with regulatory expectations and industry best practice. My extensive software development experience and first-hand knowledge of regulatory expectations can help your staff learn what is and is not required as well as how to be compliant in the most cost-effective manner.
Public Training Courses
Public training courses are usually full day or two day courses on a variety of topics. In a public course, people from different companies and backgrounds participate in discussions and interactive exercises. Not only do you benefit from the training but also from interacting with people in other companies often facing the same challenges you are.
Click here to view a current schedule of public training courses.On-site Training Courses
On-site training courses are presented to project teams and groups at your facility. This affords your staff the opportunity for everyone to hear the same message and participate in group discussions and interactive exercises. I often tailor on-site courses based on the client’s specific training needs. Tailored, on-site training provides one of the most cost-effective ways to train teams and improve skills.Contact me via E-mail: Steven Rakitin for more details on training options.
