Aligning Medical Device Software Development with EU Requirements for a CE Mark (IEC 62304) (Medical Devices)
Venue: Online Event
|Event Date/Time: Jun 14, 2011||End Date/Time: Jun 14, 2011|
This training will present an overview of the essential medical device software development standard and keys to a successful path to achieving compliance. The session will address the needs of both new companies that are developing their first medical device product, and established companies that need to align their software development processes with the standard. This knowledge is essential for those in software development, but also those responsible for product development and regulatory submissions.
Areas Covered in the Seminar:
- An overview of IEC 62304 requirements for software development processes
- The alignment of the IEC 62304 processes with design control requirements
- The alignment of IEC 62304 deliverables with requirements for the content of FDA submissions for devices that contain software
- IEC 62304 implementation for startups
- Aligning IEC 62304 with existing software development processes
- Questions and answers
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