Professor Antonio Bartolozzi, University Contract Professor, is using Embarcadero C++Builder 10 Seattle in his “Medical Device Software Design” class at the University of Trieste in Trieste Italy. The class covers both medical device standards, requirements, specifications, quality management as well as software design, development, testing and certification topics. The C++ programming language is often used in building device software, connecting with low energy devices, monitoring systems, clinical record storage, etc. With C++Builder 10 Seattle’s support for Windows, OS X, iOS and Android operating systems, the students have their choices of these popular platforms. C++Builder’s support for Classic Bluetooth and Bluetooth Low Energy (using the run time library or TBluetooth/TBluetoothLE components) also allows the students to learn about interfacing with home care and laboratory devices. Below you will find additional information about the class, class description and the course outline. You can also follow the lectures and student progress on the class LinkedIN group. If you have any questions regarding our education programs, feel free to email David.Intersimone@embarcadero.com.
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