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DEVELOPING MEDICAL DEVICE SOFTWARE ACCORDING TO IEC 62304

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 * Training
 * ISO13485
 * Developing Medical Device Software According to IEC 62304


DEVELOPING MEDICAL DEVICE SOFTWARE ACCORDING TO IEC 62304


Register for courses 60 days in advance and get 10% off this price.

Register for courses 30 days in advance and get 5% off this price

Note:Pricing is dependent on location and may vary.

Course Duration: 2 Days - 8 Hours/day

This two-day course is designed to give the attendee a detailed understanding of
developing and maintaining Medical Device Software following the requirements of
IEC 62304. The course covers the relationship of IEC 62304 with related
standards such as ISO 13485, ISO 14971 and IEC 60601.


LEARNING OBJECTIVES

 * Detailed understanding of IEC 62304 
 * Software Development Processes for Medical Devices
 * Software Maintenance Processes for Medical Devices 
 * Support Processes influencing Medical Device Software Development
 * Relationship of IEC 62304 with related standards


COURSE OUTLINE

 * Day One
 * Chapter 1: Introduction and Overview
 * Definition
 * History
 * Structure
 * Key Concepts
 * General Requirements and Software Safety Classification
 * Chapter 2: Initiation of Software Development
 * Software Development Planning and New Product Development
 * Deriving Software Requirements from System Requirements through Software
   Requirements Analysis
 * Breakout Exercise: Writing Effective Software Requirements for Medical
   devices
 * Chapter 3: Software Design
 * Software Architectural Design
 * Software Detailed Design
 * Breakout Exercise: Architectural Design

 

 * Day Two
 * Chapter 4: Software Verification and Testing
 * Unit Implementation and Verification
 * Integration and Integration Testing
 * Software System Testing and Release
 * Relationship to IEC 60601 – General Requirements for Basic Safety and
   Essential Performance of Medical Electrical Equipment
 * Breakout Exercise: Testing for Medical Device Software using Test plans
 * Chapter 5: Software Maintenance Process
 * Maintenance Planning, Problem Analysis and Modification Implementation
 * Chapter 6: Supporting Processes
 * Software Risk Management (and relationship to ISO 14971)
 * Changes and Configuration Management
 * Issue Resolution Process
 * Breakout Exercise: Performing Software Risk Management
 * Chapter 7: Integrating IEC 62304 into Medical Device Companies
 * Integrating with ISO 13485 – Medical Devices Quality Management System
 * Breakout Exercise: Integration of IEC 62304 into your Organization’s Quality
   Management System


WHO SHOULD ATTEND

 * Developers, project managers, software quality engineers and managers & other
   participants involved with the development of embedded software systems in
   the medical industry.
 * Test engineers, hardware quality engineers, hardware quality managers, and
   other participants involved with development of embedded systems in the
   medical industry will also find this course beneficial.
 * IEC 62304 implementers, internal auditors, and others who need to understand
   IEC 62304 and how to integrate it into their Quality Management will find the
   training helpful. 


COURSE MATERIALS

Each participant will receive a seminar manual including case studies. 


PRE-REQUISITE

Background in development projects, software development, quality management
systems, or medical device systems is beneficial.

A basic understanding of project management, quality management and system and
software engineering processes is also helpful, but not required.


(GERMANY)

UPCOMING TRAINING

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Training schedule available on demand. Tell me about Future Date

Provide this course Onsite
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 * Automotive
 * Electric & Autonomous Vehicles
 * Aerospace
 * Medical Devices
 * High-Tech / Semiconductors
   
 * Telecom - SCS 9001 / TIA
 * General Manufacturing

SERVICES

 * Consulting, Implementation, & Coaching
 * Training and Competency Development
 * Digital Collaboration Software Platform
 * Quality Outsourcing
 * Product Design

PROFILE

 * About Omnex
 * Omnex Group
 * Omnex Leadership Team
 * Worldwide Offices
 * Awards and Accreditations
 * Client List

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