8:15 Welcome Address And Chairperson’s Opening Remarks

Regulation & Compliance

8:30 Auditing Medical Devices Using Global Standards: A Notified Body / CE Perspective

Regulators and registrars have placed extra scrutiny on control of outsourced processes. As a Notified Body and ISO Registrar, this is the area in which we find the most nonconformities. .

• Complying with regulations for outsourcing software design, verification, validation and controlling subcontractors
• Identifying and implementing global regulations and standards related to CE submissions
• Understanding translation requirements and meeting challenges in meeting global requirements

Deborah Madsen
Senior Staff Engineer, Lead Auditor
Health Sciences Underwriters Laboratories

9:15 Adapting To Changes In The Medical Device Directive: A Case Study

• Managing compliance with the amended Medical Device Directive across products and businesses
• Organizing your company structure and process to address new regulatory requirements
• Demonstrating how GE administered the “MDD Project”
• Identifying key issues and resolutions related to changes in the Medical Device Directive including: application of the machinery directive, usability, software, labeling (phthalates & single use), dates & the supply chain, and multiple interpretations & resources

Alex Grob
Director, Regulatory Affairs
GE Healthcare

RESEARCH AND DESIGN

10:45Compliance To Intent Vs. Compliance To The Letter

• Ensuring that your compliance strategy is built into the development processes from the get go and not only a lip service
• Practicing compliance to the intent and reap the benefits of the structure
• Releasing better products with less expense and greater customer satisfaction

Charlie Gragg
Site Quality Manager
Hospira

11:30Panel Discussion: Industry Experts Compare The Challenges And Solutions In Several Medical Device Software Realms

Moderator:

Todd Burghgraef
Vice President of Engineering
DornerWorks, Ltd.

Panelists:

1:30 Principles Of Software Verification And Validation For Medical Imaging

Software dominates every step in an image’s lifecycle from initial capture to diagnostic review. But even well functioning software systems can introduce errors into the imaging data which undermine the diagnostic result. Detecting imaging problems and separating the avoidable from the unavoidable is central to answering the question “Can I trust this image?”

• Pinpointing sources of imaging problems in a software-heavy medical imaging system
• Investigating four areas of image concern to users: orientation, fidelity, measurements, and integrity.
• Understanding the roles of software engineering and risk-based verification

Alex Dietz
Manager, Software Verification and Validation
St. Jude Medical

2:15 Medical Device Interoperability - Integrating The Health Enterprise

One of the most significant healthcare industry efforts of the 21st century is the national vision of connected and interoperable healthcare infrastructure. Integrating the Health Enterprise (IHE) is a global initiative to create a framework that enables seamless interoperability of disparate systems. IHE does this by enabling sharing of vital health information from applications to applications, devices to devices and systems to systems both within and across multiple health enterprises.

• Understanding the purpose, goals, and reach of IHE
• Examining the integration profiles and standards IHE currently covers
• Learning how IHE can help companies take advantage of IHE standards to increase the interoperability of their systems with the rest of the health care systems

Murali Janakiraman
Principal Engineer
Medtronic

3:45 Achieving Shorter Development Cycles Without Sacrificing Compliance And Quality

In an age of emerging technologies, increasing competition and limited resources, companies strive to gain competitive advantage by getting to the market quicker while still providing safe, usable, high value products. With the right blend of good software design, high performance teams, engineering best practices and agile methods, companies can realize shorter development cycles and still provide high quality, regulatory compliant products that meet customer needs.

• Examining how agility is realized in the process
• Understanding the importance of team and process congruence
• Designing software for robustness, testability, and adaptability
• Learning how device virtualization allows fast and extremely efficient testing
• Leveraging tools to enable fast, robust and compliant software development practices

Paul Fernandes
Director, Software Development
U.S. Genomics

4:30 Regulatory Update From The Food And Drug Administration

Without a doubt, software for medical devices is one of the most strictly regulated areas. Please join us as software engineering expert, Richard Chapman offers the FDA perspective on major issues in software design for medical devices. This presentation will address subject areas such as static analysis and assurance cases. Do not miss this opportunity to ask questions and interact with a leading FDA expert in this space!

Richard C. Chapman, BA, MS
General Engineer, Division of Electrical
and Software Engineering, Office of
Science and Engineering Laboratories
Center for Devices and Radiological Health
U.S. Food and Drug Administration (FDA)

5:15 Chairpersons Closing Remarks And Close Of Conference