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


Instructor: Tim Stein
Product ID: 702008

  • Duration: 3 hrs
This 3 hour virtual seminar will help you 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.


Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)



Customer Care

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Email: [email protected]

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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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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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