Medical Device Software Training including IEC 62304
Software has enabled increasingly advanced functionality and interaction in medical devices. Software driven user interfaces, stand-alone software applications, and mobile medical applications are becoming prevalent within the healthcare ecosystem. Software is increasingly relied upon for improving clinical efficiency and promoting improved patient outcomes. The IEC 62304 Standard for Medical Device Software - Software life cycle process has been recognized by multiple regulatory bodies as a standard by which medical device manufacturers can support regulatory compliance claims. The IEC 62304 Standard is also now a normative reference for embedded software in medical devices through the Amendment 1 of IEC 60601-1. This one-day training session will provide the attendees with a study of the requirements for Medical Device software life cycle process.They will present examples to enable software development organizations to assure documentation practices meet regulatory requirements, and will provide strategies on how to map your organization’s current software lifecycle process to the requirements.
• Introduction to software lifecycle process • An overview of regulatory recognition of the IEC 62304 standard • An overview of the 5 key processes for software lifecycle described in the standard • An in-depth examination of each clause in IEC 62304, focusing on 5 key processes
On completion of this course, you will
• Have a working knowledge of the requirements in IEC 62304 • Have examples of how software development organizations can meet the requirements • Know how to map your development process to the requirements of the standard
Who should attend
• Software developers • R&D engineers • Product safety engineers • Compliance engineers • Product designers • Technical marketing professionals
• Date: 12 March 2015 • Cost: £300- Save when you register for both the Medical Device Interoperability & Medical Device Software Training Seminars • Location: The Manor, Huxley Close, Godalming, Surrey GU7 2AS • Register: https://eumedicaldevicesoftwareinteroperabilitytraining.eventbrite.com • For questions contact Laura Elan at [email protected] or T: +1.847.664.2330