Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Brian Shoemaker

When the Association for the Advancement of Medical Instrumentation (AAMI) published TIR 45 in August 2012, it provided the first official proclamation that Agile methods can be acceptable for medical device software. Lifecycle steps in IEC 62304, risk management under ISO 14971, and usability design according to IEC 62366 can all be addressed by a disciplined Agile team, this presentation will review the key elements. Understanding TIR 45 can be the roadmap for improving development and benefiting everyone, companies, development teams, caregivers, patients, and regulators. Key topics:

– Convergence: Agile principles and regulatory needs
– Lifecycle: incremental development, design reviews, documentation
– Key practices: planning, collective effort, product definition
– Implementation: evolving architecture, emergent design, continuous testing, traceability
– Managing your software: release, configuration management, third-party software, and CAPA

Why should you Attend: Perhaps you’re a development manager, hoping to improve both productivity and quality. Or you are a quality assurance manager, facing a demand from management and development to permit a move to Agile. Is this method acceptable, or will you be written up in your next inspection or quality certification audit? Can you indeed expect improvements if development adopts an Agile approach? Your impression has been that Agile was simply a fancy name for chaos and sloppiness – what is the truth, and where can you turn for guidance? A report from the Association for the Advancement of Medical Instrumentation, AAMI TIR 45, provides that help, and will be the subject of this webinar.

Areas Covered in the Session:
– TIR 45 comes at a much needed time
– TIR 45 stitches together the important high-level concepts
– TIR 45 outlines key practices that are needed for flexibility and quality
– Implementation issues are not ignored
– This TIR is actually just a starting point

Who Will Benefit:
– Regulatory Specialists
– Functional Managers – Software, Test, Hardware
– Other Development Specialists (Mechanical, Engineering, Other)
– Project Managers (Especially for Cross-Functional Teams)
– Software Developers
– Business Analysts
– Requirements Analysts
– Product Managers
– Portfolio Managers

Brian Shoemaker consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including agile methodology), and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics, medical device engineering, medical imaging, medical-device fabrics manufacturing, contract lyophilization, clinical trial software, dental prosthetics, and bone-repair implants. He has worked with companies in Germany and Switzerland as well as the U.S.

Previous to founding ShoeBar Associates, Brian had quality roles at PPD Informatics, Doxis, Inc., and Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.