Software Development Life Cycle training – 2 Days

What will you learn during this Software Development Life Cycle training class:

  • Presentation of the regulations and the requirements linked with the development and the validation of a software
  • Software Development Planning
  • Requirements Identification: design input
  • Design and architecture of a software
  • Implementation of a risk management process for a software
  • Tests performed on a software
  • Configuration and Cybersecurity Management
  • Maintenance of software and problem resolution: corrective and preventive action implementation

Our training sessions include presentation, exercise, case study, workshop, handouts, reference documentation or use of relevant database when applicable. The instructors are experienced and subject matter experts.

Here is the catalog of training we are currently proposing:

  • FDA cGMP Quality system conformity to CFR21-Part820 – 2 Days
  • FDA 510k submission – 2 Days
  • European Regulation of Medical Devices – 1 Day
  • ISO 13485 – 2 Days
  • ISO 9001 – 1 Day
  • Risk Management System and ISO 14971 – 2 Days
  • Software Development Life Cycle – 2 Day
  • Internal Audit and Supplier Audit – 2 Days

If you wish to participate in one of these training please contact us for a preliminary discussion.