This course provides an overview of IEC 62304 compliance when viewed from an agile perspective. It incorporates the concepts from AAMI TIR 45 with the primary objective being to understand how agile methods and approaches can be effectively used for medical device and HealthIT software while ensuring IEC 62304 conformance and meeting US FDA expectations for software documentation. The course consists of four main modules as listed below:
Mike Russell is a Partner with SoftwareCPR®. He provides firm services such as development process assessments and improvement, Quality Management System reviews, and assistance with regulatory filings. He is also an expert in business agility and “agile and compliant” process transformation. Mike served on the TIR working group that created the AAMI TIR45- 2012 Technical Information Report Guidance on the use of Agile practices in the development of medical device software.
Ron Baerg is a Partner with SoftwareCPR®. Ron has 23 years experience in medical device software development and management focused on large, complex systems with multiple computing systems containing all safety classes of software. Ron served on the TIR working group that created the 2nd edition of AAMI TIR45- 2012 Technical Information Report Guidance on the use of Agile practices in the development of medical device software.
Provides one person to connect to the course. Registration can be transferred to another person any time before 3/7/24. Refundable (minus credit card fees) until 2/29/24.
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