Becoming an expert in Medical Devices Software/SaMDs

Dear community,

I am really interested in becoming an expert in Medical Devices Softwares/SaMDs and of course guiding their developments in accordance to the regulations.
Having said that, I am aware that having knowledge about Software Engineering is helpful.

What I am looking for in this community are practical recommendations how to keep up with the changing environment in software engineering, including AI/ML because I feel like having more in-depth knowledge about software is the key to really become good at getting regulatory approval for software in the medical field.
I am open to discussing how that goal could be achieved.
I am a young professional.

Kind regards

I suggest starting with a copy of Roger Pressman's Software Engineering: A Practical Approach. This is an industry-agnostic book that will explain the totality of engineering discipline(s) for software development for an entire life-cycle. The ASQ's BoK for CSQE echoes much of what Pressman teaches... if you want some independent certification.

For medical devices, a foundation in risk management is essential for appropriate development of software. AAMI probably offers the best training.

For specific coding skills and more precisely-focused design implementations... I don't have any specific programs to point toward.

I prefer the term "Experienced" over expert. Its possible to be an expert in many things but MD software is constantly evolving. Just last week FDA dropped new guidance on cybersecurity and SBOMs so as new guidance is released the reviewers of that work also need to become experienced in it as well and that takes time. All the while technology is changing quickly too.

To your questions though ISO 62304 is a bedrock document to read and understand its application. Learn the terminology in that document.