Course Dates Upcoming Dates and Locations Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times. There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!
Course Details What You Will Learn At the conclusion of this workshop, you will be able to: Identify the deliverables for a software product submission, based on device class Determine the evidence that would be needed to support software regulatory requirements in the EU and MDSAP countries, and IEC 62304 requirements Identify the deliverables for a software product submission, based on device class Describe the regulatory framework for software Describe the IEC 62304 standard requirements for software development Explain the relationship between the software regulatory requirements and the applicable standards Provide an overview of the resources containing the key regulations, standards, and guidance documents Who Should Attend This class is recommended for software developers and those involved in non-regulatory functions associated with software. That includes: Software QA Engineers Program Managers (managing software) Software Test Engineers Scrum Master (lead of Agile development) Solution Architects Virtual Half-Days In-Person Full-Days CEUs 1.6
Related Courses Medical Device Cybersecurity Risk Training ISO 14971 Medical Device Risk Management Training Medical Device Software Development Life Cycle Training