rdm VS professional-programming

Been working as a consultant and engineer on FDA regulated software for about 8 years now. I have seen strategies from startups to huge companies.

I have seen requirements captured in markdown files, spreadsheets, ticket management systems like Redmine, Pivotal, Jira, GitLab, Azure Devops, GitHub Issues, and home grown systems.

If I had to start a new medical device from scratch today, I would use Notion + https://github.com/innolitics/rdm to capture user needs, requirements, risks, and test cases. Let me know if there is interest and I can make some Notion templates public. I think the ability to easily edit relations without having to use IDs is nice. And the API makes it possible to dump it all to yaml, version control and generate documentation for e-signature when you need it. Add on top of that an easy place to author documentation, non-software engineer interoperability, discoverable SOPs, granular permissions, and I think you have a winning combination.

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We've had somewhat of a hard time applying agile to IEC 62304, although it's not impossible.

This document has some useful tips:

AAMI TIR45:2012 (R2018) Guidance On The Use Of AGILE Practices In The Development Of Medical Device Software

Also, we have an open source offering that includes an IEC62304 compliant software plan. You can check this out here:

https://github.com/innolitics/rdm/blob/master/rdm/init_files...

The inclusion of the perspective section: https://github.com/charlax/professional-programming?tab=read... I think is really smart. Same for personal productivity. Two things that can dramatically change how and what you end up studying and doing with your time / life.

I did a coding bootcamp and yeah the frontend knowledge they taught was useful, but I could have learned that online for free. Looking back, the far more valuable thing I learned was how to discipline myself and my time - that was the first time in my life I was truly disciplined and mindful in how I spent my time. I also got perspective I'd never seen before: there was some folks in my cohort that were in their 30s and 40s and undergoing career change, and I learned two things from them: First, don't stress too much, your life has much more flexibility than you might expect (this truth is borne out, they all have perfectly successful careers in their new lives as engineers), and second, make a great use of the time you have.

Bog-standard advice we all know, but to witness it firsthand from people living it and sharing it is different. The shared article in the github is incredible: https://www.theguardian.com/commentisfree/2020/sep/07/termin...

I often wonder why I don't see more of these sorts of articles. From watching a family member slowly die of cancer, and from reading books like "When Breath Becomes Air," I'm guessing it's some combination of exhaustion, disability, and a new set of priorities that doesn't really involve death blogging. Still, I find these kinds of writings more poignant than most things I read.

Also this repo helps https://github.com/charlax/professional-programming

1. Professional Programming

Professional Programming. As reported, The goal of this page is to make you a more proficient developer. If you have excellent resources, you can try to open a PR and include them here. But in any csae, I wanted to include this because it seems super interesting.