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Medical Device Software Lifecycle Processes

Picto Training Medical Device Software Lifecycle ProcessesCourse Objectives

  • Knowledge of the European regulatory requirements (Medical Directive 2007/47 / EEC) and US (FDA) related to the development and software validation.
  • Identify and understand normative documents or useful guides to claim conformance to regulatory requirements.
  • Know how to implement the quality management principles for the development of software medical devices.

Program

Day 1

  • Welcome and Introductions
  • The Regulation: the regulatory provisions relating to the development and software validation
  • Introduction to the US and European requirements
  • Introduction to standards and guides available to industry to address regulatory requirements
  • Planning software development
  • Defining Requirements (System Input Data)
  • Building & Design of software

Day 2

  • Implementation of a risk management process applied to software
  • Testing carried out on the software
  • Configuration and cyber Security management
  • Software Maintenance and resolution of software issues: how to apply a corrective and preventive actions process?
  • Course evaluation, synthesis and conclusions

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We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

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Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

ISO13485 Training

Transition to ISO 13485:2016
1 Day Course

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

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Santa Clara, CA