3-hr Virtual Seminar: Outsourcing Medical Device Software Development with Compliance to IEC 62304


Instructor: Tim Stein
Product ID: 702133

  • Duration: 3 hrs
This 3-hr webinar will show how a medical device company can work with the software developer to establish IEC 62304 compliant processes, and ensure that the software developed meets IEC 62304 requirements.
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Why Should You Attend:

In order for a medical device company to meet the requirements for a CE mark, the software must be developed in a manner that meets the requirements of IEC 62304, “Medical device software-Software life cycle processes.”

But. most software development vendors don’t understand IEC 62304 well enough to ensure compliance. As a result, the software is developed in a manner that is not compliant, and the documentation required by IEC 62304, and needed for the FDA submissions, is not created by the developer.

In this webinar, common issues related to ensuring that outsourced software is developed in compliance with IEC 62304 will be addressed. The training will also include an overview of IEC 62304 because the first step to managing a vendor for compliance is to understand the standard.

Areas Covered in the Seminar:

  • Common compliance issues in using software development vendors to create medical device software.
  • IEC 62304 requirements for software development processes and documentation.
  • FDA documentation required for premarket submissions for products containing software (IDE, 510k, PMA).
  • Models of outsourced software development services. (In all cases, the vendor develops the software, but arrangements vary widely on how testing is done and how the preparation of the documentation is split between the vendor and the medical device company.).
  • Vendor qualification of software developers.
  • Setting expectations.
    • Statement of work covering deliverables and roles and responsibilities of the company and vendor.
    • Quality agreement covering development processes.
  • Collaboration during development.
  • Software development procedures needed by the:
    • Medical device company.
    • Development vendor.
  • Using the development vendor for on-going defect repair and software enhancement: responsibilities, coordination, change control and record keeping.
  • Questions and answers.


  • Models for outsourcing the development of medical device software.
  • Software development deliverables and the roles and responsibilities of the medical device company and development vendor in creating the deliverables.
  • A list of the software development procedures needed by the company and the development vendor.

Who Will Benefit:

  • Medical device companies that outsource  software development
  • Software development vendors who develop medical device software
  • The individuals who will benefit include:
    • Software development managers and engineers
    • Software quality assurance managers and engineers
    • Quality Assurance managers
    • Product engineering managers
    • Product program managers
    • Product development project managers

Instructor Profile:

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 95 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).

For the past couple of years, Tim has focused on IEC 62304 gap analyses and providing leadership in establishing compliant software development processes, including companies that outsourced software development.

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

Tim has given 31 public presentations in the past nine years. He is a Fellow of the American Society for Quality and a member of both the Medical Device and Software Quality Divisions. Tim holds a Ph.D. in organizational psychology.

Topic Background:

The revised MDD regulations that became effective in March 2010 added an essential requirement that medical device software be developed following state of the art software development processes. As a result, notified bodies are now demanding compliance with IEC 62304, “Medical device software-Software life cycle processes,” as a condition for a CE mark. IEC 62304 also is the only FDA consensus standard for software development.

Medical Device software development is commonly outsourced by both startups and well established companies. Such software must be developed under an IEC 62304 software development process. The problem is that many custom software development companies do not use practices that comply with 62304. The medical device company must work with the software developer to establish processes that are compliant with IEC 62304, and to ensure that the needed deliverables are created and that the deliverables meet the IEC 62304 requirements.

The problem is that many custom software development companies are not trained on IEC 62304 and do not use practices that comply with the standard. This can be true even when the company has experience developing medical device software. Many medical device companies assume that the vendor will develop their software using a compliant process, and they don’t understand IEC 62304 well enough to ensure compliance by the vendor.

Common issues related to ensuring that outsourced software is developed in compliance with IEC 62304 include:

  • How to qualify the vendor
  • Ensuring acceptable software development processes when the vendor doesn't have a formal process, or their process is not compliant with IEC 62304
  • Defining roles and responsibilities for the creation and approval of deliverables
  • How to ensure that the software meets your requirements
  • How to fix bugs and enhance software developed by an outsourced vendor
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