Brian Shoemaker provides consulting services and training in computer system validation, software quality assurance methodology, and electronic records and signatures. His projects have included validating process-equipment software, validating embedded medical-device software, developing software quality systems, assisting companies through regulatory-compliance projects, and evaluating systems for 21 CFR Part 11 compliance. His clients have included firms in the medical-device fabrics manufacturing, plastics molding, contract lyophilization, outsourced medical device engineering, clinical trial software development, dental prosthetics, and bone-repair implant fields. He has worked with companies in Germany and Switzerland as well as the U.S.

Previous to founding ShoeBar Associates, Brian served as Quality Assurance Manager at PPD Informatics (now CSS Informatics), QA/Validation for Doxis, Inc., and Systems Engineering Manager at Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.

Robert joined Renishaw plc in 1988 as an electronics engineering apprentice and then later obtained a BEng (Hons) in Electronics Engineering. In 1997 he moved into software and systems design, involved in many embedded and Windows-based products for the company, later becoming software development manager for neurosurgery software in 2008.

Robert was responsible for putting together the first team to practice agile development in the company and has been practicing agile for the past 3 years as a scrum master. The first CE marked medical device using agile development was successfully released to market in January 2012.

He has recently moved into the role of product owner for the next version of the medical device software which is under development. Again using agile, learning from pitfalls of the previous project and continually looking to improve the process for developing software for the healthcare market.

Lucien studied Physics at the Eindhoven University of Technology. After that he started working in the field of technical automation, working in that area for more than 10 years as a contractor mostly in the area of machine control software on PC (low volume/high price), but also embedded software (high volume/low price). In this role he worked in teams of various sizes, from 10 people (in an 80 FTE project) to 2 in a 2 FTE project.

Lucien started started working at Philips Innovation Services – SES (part of Philips Corporate Technologies) in November 2004. SES has always been an agile software development organization. SES moved into the medical domain quite recently, since 2009. He is currently the Project Leader there, with the main task of his organization to support Philips Research in turning their ideas into a working prototype, or even production of a small series (5 – 20 pieces).

Steve is Software Engineering Manager for Napp Pharmaceuticals and also the current chairman of the DSDM Consortium. Steve has been involved in Agile since its inception, DSDM being one of the signatories of the Agile Manifesto, and also was pioneering iterative approaches to software development from the mid 1990s. As well as managing many agile projects, Steve has implemented DSDM, into the highly regulated pharmaceutical industry. Steve is a Certified DSDM Practitioner, Trainer and Examiner and has co-authored papers on DSDM and PRINCE2, Applying DSDM in offshore environment and Using DSDM with PMBOK. Steve is also on the Consortium editorial board. Accredited in project management techniques such as PRINCE2 Steve still firmly believes the best training is through experience and in his 30 years has undertaken all of the IT roles from trainee programmer through to project manager for large 6 figure projects.

Hagai Livni has been working in the software verification and validation field for the last 16 years. Starting as an SQA engineer in Tescom, a professional services firm providing software quality assurance and testing expertise, he earned experience in a wide variety of industries producing software solutions including MRP, GIS, CAD, and IT systems.

Hagai joined Given Imaging in 2000 when the company was a 2 year old startup company with a science fiction idea. Here he had the opportunity of building up, leading the SQA department and bringing it to become a skilled and professional group, that performs all software quality assurance activities for Given’s products, production software and quality system software.

Mike was educated as a practical engineer in electronics and graduated with a B.Sc. in computer science from Israel Institute of Technology.

In the past he has worked as a software developer for a startup company that developed advanced video cameras, but since 2000, he has been working for Given Imaging as a senior software developer and in the last couple of years as a team leader and software architect. Mike has experience in Software design and development, agile software development, and SCRUM master.

Sune Sorensen joined the healthcare and medical device sector one year ago, bringing with him extensive experience from software development consultancy companies. His focus is to create highly effective software development teams and organizations based on agile and lean principles and tools, in order to bring complex and highly user friendly products fast to the market. He currently works as a Software Manager for New Technology Projects at Radiometer Medical in Denmark.

Kelly Weyrauch is a Senior Principal Systems Engineer at Medtronic, with 20 years experience in delivering medical device software for pacing and defibrillation systems. As a leader of the Agile movement within Medtronic, he lead the adoption of Agile within the context of the highly regulated, Class III medical device software environment. As one of the lead authors on the AAMI Committee that produced the Technical Information Report, "Guidance on the Use of Agile Practices in the Development of Medical Device Software", Kelly worked with other industry and FDA leaders to provide guidance to the medical device industry and regulatory worlds. As a leader in the Agile community, he has blazed the trail for using Agile in the regulated world, overcoming barriers by tailoring the use of Agile to align with regulatory expectations. Kelly is an experienced definer, designer, teacher, facilitator, and coach. He has a BS in Mechanical Engineering from the University of Minnesota, and a MS in Software Design and Development from the University of St. Thomas.

After 7 years in software development for military firearms and flight simulation, Tim had a crisis of conscience and switched to the medical device industry. For the last 12 years he has worked for Elekta Ltd. developing software for their world-class radiotherapy equipment and maintaining the software department’s quality system in line with the changing regulatory landscape and Agile/Lean practices. Tim has lead many process improvements including those to bring the quality system in line with IEC62304, IEC60601-1-6 and IEC62366. He has also driven the adoption of Agile software development techniques within the regulatory framework and introduced new tools to support the transformation allowing simple extraction of data for succesful regulatory submssions.

Having been involved with DSDM since its evolution in 1994, Julia was instrumental in establishing its core accreditations and played a key role in establishing the original Training and Accreditation group. As a board director (1997 – 2001) she was also responsible for the International and Member Services Workgroups. She is a certified DSDM Practitioner, Trainer & Examiner having delivered DSDM training (all versions) across the world. Julia is also a Certified Scrummaster. She was also instrumental in establishing the Facilitator Accreditation Services where she was one of the first examiners. Facilitation, one of the core techniques of DSDM, remains a strong focus for Julia, along with general Agile, project management and risk management.

Julia retains a passion to see the Agile best practice within DSDM used internationally, and supports those practising DSDM wherever they are. She has worked with both large and small organisations to implement DSDM, including the tailoring of the organisational processes to fit agile. Some of which have included the use of Agile techniques within programmes and portfolios. The use of Agile at enterprise level is also a key element of her vision.