Medical Device Software Development & Management - Comprehensive Training Package (4 Courses)

Medical device software can make or break a device. Badly developed, non-compliant software can compromise a device's safety and reliability.

These four webinar recording CDs cover not just the IEC 62304 requirements for medical device software development, but how to do risk analysis on software; a risk based approach to verifying and validating software and using an IQ/OQ/PQ approach to validating software.

How It Works:

Each webinar CD has a series of modules. Our speakers have delivered the modules using PowerPoint slides.

This training is convenient to attend individually or in groups. You don’t have to travel from your office. This means you can afford to have your whole team attend. As the webinar recording CDs are licensed to be used multiple times in a location, you can schedule the training as many times for as many groups/batches as you wish. Your team members will learn the material together; everybody will get the same information.

Webinar Topics included in this package:

• Medical Device Software Risk Analysis
• Using an IQ / OQ / PQ Approach to Validating Medical Device Software
• Aligning Medical Device Software Development with EU Requirements for a CE Mark (IEC 62304)
• Risk-Based Software V&V - FDA, GAMP®, 14971

Who will benefit?

These webinar recording CDs will be beneficial to the following:

All medical device companies whose products contain software; software development management; software development engineers; software quality assurance managers; software quality assurance engineers; Quality Assurance managers; Product engineering managers; Product program managers; and Product development project managers.

Webinars included in the Package:

Course 1 : Medical Device Software Risk Analysis

Duration : 60 minutes
Last Recorded Date : Jun-2008

This webinar discusses the use of risk analysis techniques applied to medical device software including discussions of pitfalls in the process of risk analysis.

Areas Covered in the Webinar:

• Identifying software defects and software functions that could result in hazardous situations leading to harm.
• Determining Intended Use for the risk analysis process.
• Identifying known and foreseeable hazards.
• Identifying the cause of software hazards.
• Estimating the risk of software hazards.

About the Instructor:

Edwin Bills, was Industry Co-chair for the AAMI Committee AAMI/QM/WG 04 Application of risk management to medical devices, representing the United States on ISO TC 210 Joint Working Group 1 which developed the ISO 14971 standard.

Course 2 : Using an IQ / OQ / PQ Approach to Validating Medical Device Software

Duration : 60 minutes
Last Recorded Date : Feb-2016

This Medical Device Software Validation training will show how you can validate software, using IQ / OQ / PQ methodologies typically employed for process validation.

Areas Covered in the Webinar:

• Development of software test plans.
• How to apply IQ / OQ and PQ techniques to software?
• Risk based software testing.
• How does Software Validation relate to Design Validation?
• Typical software tests.
• What is the appropriate sample size for software testing?
• Software issue tracking.
• How to address open issues when releasing software.

About the Instructor:

Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries.  Mercedes has over twenty-five years of experience in the Medical Device industry.

Course 3 : Aligning Medical Device Software Development with EU Requirements for a CE Mark (IEC 62304)

Duration : 2 hours, 19 minutes
Last Recorded Date : Feb-2014

This webinar show how you can create an integrated medical device software development process that will meet IEC 62304 and ISO 13485 design control requirements, and generate the documentation needed for software as part of a FDA submission.

Areas Covered in the Webinar:

• An overview of IEC 62304 requirements for software development processes.
• The alignment of the IEC 62304 processes with design control requirements.
• The alignment of IEC 62304 deliverables with requirements for the content of FDA submissions for devices that contain software.
• IEC 62304 implementation for startups.
• Aligning  IEC 62304 with existing software development processes.

About the Instructor:

Tim Stein, is the President and CEO of Business Performance Associates, Inc., a consulting firm located in Cupertino , California , that he founded in 1994. Tim's has provided service to over 90 clients in software development processes, quality systems, and computer system validations. Tim also served as the Director of Software Validation and Quality Assurance at Genomic Health, Inc. (GHI).

Course 4 : Risk-Based Software V&V - FDA,GAMP®, 14971

Duration : 90 minutes
Last Recorded Date : Jun-2008

This risk-based software V&V training will guide you through 11 "must have" elements of software validation and how to use your Risk Management Tools (per ISO 14971:2007).

Areas Covered in the Webinar:

• Verification or Validation -- Recent Regulatory Expectations.
• The Project Validation Plan.
• Software Product Validation - how it differs from process / equipment V&V.
• When and How to use DQ, IQ, OQ , PQ ?
• How to use your Risk Management Tools (per ISO 14971:2007)?
• GAMP® guidance.
• The 11 "must have" elements of software validation.
• White box and/or "black box".
• Some "real world" test case examples.

About the Instructor:

John E. Lincoln, Consultant, has successfully developed and implemented and trained to device, pharma, medical gases, and dietary supplements CGMP-compliant systems. He has conducted compliance audits in all these areas. His systems have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles, and workshops, worldwide.

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