jdgiese

CK2, what makes you think that FDA cleared only means it’s “extremely similar to other approved devices”?

I think you may be confused, or are repeating something you heard in a Netflix documentary.

First, “fda cleared” means your device is “substantially equivalent” to another cleared or granted device. You can’t be cleared based on another approved device, since approval means the other device received a PMA. Second, substantial equivalence is actually quite lenient. I know, because I’ve helped clear over 50 devices.

Finally, a cleared device still can require a lot of testing. Frequently FDA requires our clients to run multimillion dollar studies to validate their devices.

Innolitics | https://innolitics.com/join | Remote | Full-Time

Innolitics' is helps bring AI-enabled regulated medical software onto the US market. We focus on righting high-quality, clearly documented code and helping our clients with regulatory submissions. We care about safety and cybersecurity.

We're an organized, established team and have been in business 15 years, helping 100s of companies onto the market in radiology, cardiology, neurology, and other fields.

Principal Medical Device Software Engineer - $200,000–$250,000/year + 10-12% bonus. Required 15+ years experience as a software engineer and 8+ years of experience in the medical device space.

Staff Medical Device Software Engineer - $170,000–$200,000/year + 10-12% bonus. Requires 10+ years experience as a software engineer and experience going through at least one 510(k) or De Novo.

Innolitics | https://innolitics.com | Medical Device AI/ML Engineer | REMOTE | Full-Time | $120,000 - $150,000 + benefits | US Only |

Innolitics helps companies build and FDA-clear healthcare AI.

Requires at least 3 years of full-time experience in AI/ML development work.

Apply here: https://innolitics.com/join/medical-device-ai-ml-engineer/

I love Notion and use it extremely heavily. I've also built a few integrations with Notion. I think it's a great app that uses AI very well, and they continue improving. Hopefully they fix this though! Also, their API has recently been upgraded quite a bit and now supports database views as a first class object. I have a few other small requests regarding their public API.

Innolitics | Multiple Roles | Fully Remote | https://innolitics.com

We help companies develop medical AI and navigate the FDA's regulations. We're industry leaders in a niche, growing space.

Medical Device Software Engineer (https://innolitics.com/join/medical-device-software-engineer...)

Senior Web/Mobile Medical Device Engineer (https://innolitics.com/join/senior-web-mobile-medical-device...)

Senior Regulatory Affairs Specialist AI/ML SaMD (https://innolitics.com/join/senior-regulatory-affairs-specia...)

Physician-Scientist (MD or equivalent) – Biostatistics & ML Development for Medical Device AI (https://innolitics.com/join/physician-scientist-md-or-equiva...)

Checkout our website for lots of details about what we do.

Innolitics | Software Engineering | Remote (Continental US) | Full Time

Innolitics is a remote-first company specializing in medical device software development and FDA regulatory consulting. Since 2012, we’ve partnered with medical device companies to bring innovative technologies to market. Our team of engineers, consultants, and domain experts works at the intersection of software engineering and regulatory compliance to deliver high-quality solutions.

As an engineer here, you will not only write production code, but also develop expertise in medical device regulations, quality systems, verification and validation, and the realities of FDA-facing software.

If you’re excited by the intersection of technology, medicine, and regulation—and enjoy organizing and clarifying complex information—you’ll feel at home here.

Roles currently available:

Senior Web/Mobile Medical Device Engineer : https://innolitics.com/join/senior-web-mobile-medical-device...

Physician-Scientist (MD/PhD) – Biostatistics & AI Software Development for Medical Device AI : https://innolitics.com/join/physician-scientist-md-phd--bios...

To apply, view the URLs and follow the instructions at the bottom of the page.

Innolitics | US-Based | Remote | Full-time

Innolitics is a remote-only professional services firm. We help medical device companies—from startups to large corporations—develop software and AI for medical devices, validate safety and security, and navigate FDA regulations.

At Innolitics, we are at the forefront of a rapidly evolving industry that increasingly relies on software and AI. As part of our team, you’ll work on projects that improve patient care and safety. From developing AI-driven diagnostics to ensuring cybersecurity, you’ll push the boundaries of what's possible.

In this dynamic field, both regulations and technology are constantly changing. Success requires continuous learning and growth. We foster a collaborative and flexible environment that encourages this.

$120k - $130k + 10% bonus + 3% 401k + benefits

To apply, see https://innolitics.com/join/medical-device-software-engineer...

https://goodlifeodyssey.com - it uses Notion as the CRM and there are a few AWS lambdas that publish to an S3 bucket

We're the authors of n2y. We use it extensively and it is quite robust at this point. It maps Notion content into Pandoc's AST and provides a plugin system for dealing with information that's not easily representable in the AST.

Congratulations on putting together such a nicely designed app. I definitely noticed the quick download time when I installed it to check it out.

I run a medical device software development firm. I'm a software engineer who has moved into the medical-device regulatory affairs. I've helped several software teams learn to develop (and document) software for medical devices.

Even if you're not planning to make the jump from a wellness app to a medical device for a while, there are some things you can start documenting now that will make the transition a lot easier for you when you get there. E.g., starting to track formal requirements (https://innolitics.com/articles/2022-04-27-design-inputs/) and tracing them to verification protocols.

We have a bunch of Notion templates that we use with our clients that I could share with you to help you get started. Feel free to email me at jdgiese AT Innolitics.com

Innolitics | Software Engineer | Full-time | Remote

We're a remote-only team of 14 software engineers helping accelerate progress in the medical device industry. Our founders are both biomedical engineers and software developers, uniquely positioning us to understand and implement our clients' needs. Investment in the medical device industry is booming due to COVID, and AI/ML is making its way into the clinic. It's a good time to be in this space and we expect to grow significantly over the next few years.

We're looking for a well-rounded engineer with web development experience to work with our clients, helping them write software for their medical devices.

Some technologies that we commonly use are Python, TypeScript, C++, Django, TensorFlow, and React.

The salary for the position is $95k - $125k/year, depending on ability and experience. We also have overtime pay and bonuses.

We're remote-only, respect work/life balance, and value on-going learning.

For more information check out the job description: https://innolitics.com/join/engineer-with-web-experience

How long have you been following this procedure?

Innolitics | Software Engineer | Full-time | Remote US time-zones | 95 - 125K + Benefits

https://innolitics.com/join/engineer-with-web-experience

We're a remote-only team of 12 software engineers helping accelerate progress in the medical device industry. Our founders, are both biomedical engineers and software developers. We've found some better ways of writing medical-device software that we believe will transform the industry. You can help us make this happen.

Investment in the medical device industry is booming due to COVID, and AI/ML is making its way into the clinic. It's a good time to be in this space and we expect to grow significantly over the next few years.

You’ll work with one of our clients, helping them write software for their medical devices. We usually follow an agile process and demo any notable progress to clients once a week. You’ll be responsible for gathering requirements from the client, architectural design, coding, testing, risk analysis, and documentation. You’ll also be responsible for reviewing other engineer’s code (and your code will be reviewed too).

Agreed! I live in NYC and don't drive too often. I just got back from a two-week trip with a car rental and was really surprised at how great Apple Maps was. The map design is nice and clean and it works well with CarPlay. I also felt like the audio instructions were very clear and easy to follow. E.g., "pass this light and turn right at the next one." I also liked the "Share your ETA" feature which I used a few times. Really nice job Apple!

Innolitics | Software Engineer | Remote (US except CA, HI, or AK) | Full Time | https://innolitics.com

We're a remote-only team of 12 software engineers helping accelerate progress in the medical device industry. We're doing this in a few ways: First and foremost, we help our clients write software for their medical devices. Second, we create tools to help startups efficiently navigate this highly regulated industry. Third, we share our knowledge through the articles we write.

Why would you want to work with us?

  - meaningful work
  - small, profitable, and growing
  - many opportunities to learn new technologies
  - talented and fun teammates
  - work/life balance (and overtime pay)

Learn more about us, the job, and how to apply here:

https://innolitics.com/join/engineer-with-web-experience

We’re fully remote and have hired a few engineers out of college. They’re very independent and productive. Who knows if they’d be even better if they worked onsite, but I doubt it.

Innolitics | Software Engineer | Full-time | remote

We help radiologists (and other clinicians) turn their ideas into medical software.

We're remote-only, respect work/life balance, and value on-going learning.

We're looking for a well-rounded engineer with some web-development experience. We mostly use Python, Django, React, and TypeScript.

See https://innolitics.com/join/engineer-with-web-experience for more details.

The application process is simple:

20 minute fizz-buzz like quiz

45 minute phone interview

90 minute technical interview

The first half of the technical interview is practical questions like: "How does a browser's event loop work?". The second half is a live coding a solution to an algorithm problem. You'll finish the problem after the interview and submit your solution.

Innolitics | Scientific Software Engineer | Distributed team (All in continental USA) | Full-time

We help medical device companies write software.

See https://innolitics.com/join/engineer-with-scientific-computi... for details and

$90k-$125k + bonuses + 3% automatic 401(k) contribution

We're also have a couple of other openings ( see https://innolitics.com/careers/ )

We use a very similar approach at Innolitics when working on medical-device projects for our clients. We've been slowly creating an open source tool to help streamline all of this (https://github.com/innolitics/rdm). We've used this tool to write 510(k)s for three of our clients now and have a couple of more submissions in progress. Each time we go through it we improve the tool a bit.

It handles requirements gathering, documentation generation, regulatory audits, and design documents. We also have been playing around with Structurizr DSL and so far like it quite a bit. We also have a backend that integrates with GitHub and plan to add backends for GitLab and Jira soon.

We've used the document-driven approach effectively at our company retreats (https://innolitics.com). We plan to use it more frequently as we grow (we have 12 engineers and are hoping to hire a couple more this month).

I've heard this idea repeated several times from people I respect, and thus I take it seriously. That being said, I've seen some contrary evidence. At Innolitics, we've hired several engineers out of college who've blossomed into talented and independent contributors within a couple of years. I'm not sure if we're doing something special or different that has solved the "junior's need face-to-face learning" problem, or if it's not as much of a problem as many people think.

Innolitics | A couple of mid-level and senior positions | Full-Time | Remote

We're a growing medical-device software-development firm.

Check out our handbook (https://innolitics.com/about/handbook/), or the links below, for more info about our company.

1. Software Engineer ($80k–$110k + bonuses) https://innolitics.com/join/engineer-with-web-experience

2. AI Software Engineer ($90k–$125k + bonuses) https://innolitics.com/join/engineer-with-scientific-computi...

3. Principal Engineer ($145k–$190k + bonuses) https://innolitics.com/join/principal-engineer

4 seems like it is a particular instance of 2

Thanks! We think so too. It's a daunting task to go from ISO13485 or IEC62304 to a set of process documents. We hope to continue improving RDM to lower the barrier for researchers and startup founders in the space. We're about to add templates for a low-overhead QMS within the next week or two.

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...

> Tipping is demeaning and derogatory to the person being tipped, especially in the manner it is done.

Why?

> - if inkscape writes out a partial file because full disk and you fix the problem, the partial svg will no be rebuilt

You can use the `.DELETE_ON_ERROR` phony target to solve this problem. You can read more about this in this short article:

https://innolitics.com/articles/make-delete-on-error/