3-hr Virtual Seminar: Aligning Medical Device Software Development with EU Requirements for a CE Mark (IEC 62304)

Why Should You Attend:

This training will present an overview of the essential medical device software development standard and keys to a successful path to achieving compliance. The session will address the needs of both new companies that are developing their first medical device product, and established companies that need to align their software development processes with the standard. This knowledge is essential for those in software development, but also those responsible for product development and regulatory submissions.

This webinar will provide an opportunity for you to achieve one integrated software development process that will meet the IEC 62304 requirements and the FDA and ISO 13485 design control requirements, and generate the documentation needed for software as part of a FDA submission.

A practical guide to implementation will be presented that focuses of success factors learned through successful implementation projects with several medical device companies.

Areas Covered in the Webinar:

• An overview of IEC 62304 requirements for software development processes
• The alignment of the IEC 62304 requirements with FDA and ISO 13485 design control requirements
• The alignment of IEC 62304 deliverables with requirements for the content of FDA submissions for software in medical devices
• Path to IEC 62304 compliance
• Modifying existing software development processes to comply with IEC 62304
• Implementation pitfalls
• Success factors in achieving IEC 62304 compliance with outsourced software development
• Questions and answers

Free handouts:

• Alignment of IEC 62304 Deliverables with Design Control Requirements
• Alignment of IEC 62304 Deliverables with Requirements for FDA Submissions for Devices Containing Software

Who Will Benefit:

This webinar will provide valuable assistance to all medical device companies whose products contain software. The individuals who will benefit include:

• Medical device software development managers
• Software development engineers
• Software quality assurance managers
• Software quality assurance engineers
• Medical device quality assurance managers
• Medical device product engineering managers
• Product program managers
• Product development project managers
• Regulatory compliance professionals
• Software vendors in the medical device industry
• Documentation

Instructor Profile:

Dr. Tim Stein, Ph.D. 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 100 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).

Tim has performed IEC 62304 gap analyses and provided leadership in establishing compliant software development processes for many companies.

He is the author of a hands-on compendium for computer system validation, The Computer System Risk Management and Validation Lifecycle, Paton Press, 2006, 600 p.

Tim has given over 40 public presentations in the past eleven years. He is a Fellow of the American Society for Quality and a member of both the Medical Device and Software Quality Divisions.

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