Course Title: Medical Device Software Design
The course is a reading and discussion subject on advanced topics in the engineering of medical device software systems. Focus on software design & development and standards IEC 62304/IEC 14971. Topics differ but are chosen from: MD software process and lifecycle; requirements development, specification and analysis; design principles; medical device standards; testing, formal analysis, and reviews; quality management and assessment; product and process metrics; SOUP and reuse; evolution and maintenance; team organization and people management; software engineering aspects of programming languages; and software psychology.
This course covers
- Advanced knowledge of medical device design & support including firmware design, servicing, inspection repair, calibration, quality control, safety, preventive maintenance, acceptance testing and procurement.
- Regulatory Affairs and Medical Devices experience (ISO 13485) to establish Regulatory submissions
- Expert design of industrial and medical devices: patient monitor systems, home care devices, electrocardiographs, clinical record software, real-time software.
- Proficiency in conducting work groups arranged to project products, produce medical devices and offer post-sale assistance.
Skills, Technologies and Specialties covered/learned in the course:
Project Management, EHR design, medical device & firmware design, Coding with C / C++, Working knowledge of medical sensor & actuator technologies, experience working with UML specification & design, RTOS & Embedded Operating systems, software risk analysis, medical standards (ISO 62304, ISO 14971, ISO 13495), medical device directives (93/42/ECC, 2007/47/EC) and basic FDA requirements .
· Quality management system (ISO 13485)
· Software risk management
· Software safety classification
· Software development process
o Software development planning
o Software requirements analysis
o Software architectural design
o Software detailed design
o Software unit implementation and verification
o Software integration and integration testing
o Software system testing
o Software release
· Software maintenance process
o Establish software maintenance plan
o Problem and modification analysis
o Modification implementation
· Software risk management process
o Analysis of software contributing to hazardous situations
o Risk control measures
o Verification of risk control measures
o Risk management of software changes
· Software configuration management process
o Configuration identification
o Change control
o Configuration status accounting
· Software problem resolution process
· Medical software analysis, design, development, validation and verification
· Laboratory: Medical device design and programming
Follow the Course on LinkedIN
You can follow the course using the LinkedIn group: https://www.linkedin.com/groups/8488024