Developing software in compliance with FDA, EU regulations and international standards is challenging. This two-day intensive course provides practical guidance and suggestions for developing software that complies with applicable FDA and EU regulations, FDA guidance documents related to software and international standards including IEC 62304 and ISO 14971. The focus of this course is interpreting the FDA QSR regulation and guidance documents for software. Each section of the FDA Design Controls regulation (820.30) is discussed from the software perspective along with corresponding requirements from IEC 62304.
In-depth discussion of critical topics such as Requirements, Software Verification & Validation, and Risk Management are included. In addition, techniques for validating software development tools and software used in Manufacturing and Quality Systems are also discussed. Interactive group exercises are included to facilitate discussion and learning.

Who Should Attend?

Software and firmware engineers, software managers, RA/QA staff, validation engineers, and project managers. Anyone interested in learning how to develop medical device software in compliance with regulations, standards and guidance documents.