Industry 4.0 and technological evolution, including artificial intelligence (AI) tools, has generated a mass of mobile applications and software based medical devices: both Software as a Medical Device (SaMD) and Software in Medical Devices (SiMD). As always the development of regulations is slower than the technology, but manufacturers and sponsors must have a clear understanding of the unique nature of these software systems and their compliance requirements if they wish to bring them to market.
This course will help you understand the lifecycle processes, regulatory requirements and validation guidance for Software as a Medical Device (SaMD) within the Australian and international regulatory frameworks.
Content
- Introduction to Software based Medical Device;
- Software as a Medical Device (SaMD)
- Software in a Medical Device (SiMD)
- Risk Categorisation of SaMD
- Mobile Medical Applications
- Artificial Intelligence Medical Devices
- Regulatory Requirements and Current Trends
- Software Medical Device – Software Lifecycle Processes
- Design and Development of Medical Devices
- Workshop: Is my Software a Medical Device?
- Computerised System Validation (CSV) for Software based Medical Device including Mobile Medical Applications;
- Verification
- Validation
- Quality Management System (QMS) for Software based Medical Device
- Cybersecurity
- Workshop: What is the Regulatory and Compliance pathway?
Participants
This course will benefit you if you are a software-based medical device software engineer/developer or a sponsor or manufacturer of SaMD products. You may be working in Design/Engineering, Validation, Production/Manufacturing, Regulatory Affairs, Quality Assurance or Quality Control.
Format and Course Length
The course will be delivered as an online virtual-classroom training session.
Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.
The training will be delivered as 2 x 3.5 hour sessions over 2 days. Breaks are included.
An online quiz assessment will be issued by SeerPharma on e-mail after delivery of the course is complete.
What Do I Need?
Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.
Sessions
Participants will attend both half-day sessions:
| Sessions | Dates | Times |
| Day 1 | 20 August 2024 | 9:00am-12:30pm |
| Day 2 | 21 August 2024 | 9:00am-12:30pm |
Times are based on Melbourne, Australia.
Fee and Discount
- AUD $700 (excluding GST) per participant
- A 10% discount applies for 3 or more participants from the same company
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Contact us for clarification or to discuss your interest in a public or private delivery of this course.
