jdgiese
Joined 14 years ago
Karma
197
Submissions
119
Member since
Sep 14
Recent submissions
Comment · 20 days ago
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.
Comment · 1 month ago
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.
Comment · 6 months ago
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/
Comment · 6 months ago
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.
Comment · 7 months ago
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.
Comment · 8 months ago
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.
Comment · 9 months ago
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...
Comment · 9 months ago
https://goodlifeodyssey.com - it uses Notion as the CRM and there are a few AWS lambdas that publish to an S3 bucket
Comment · 2 years ago
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.
Comment · 3 years ago
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 (e.g., automated or manual tests).
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
I'm also the CEO and Co-Founder of Innolitics (innolitics.com).
Our mission is to accelerate progress in medical imaging by sharing knowledge, creating tools, and providing quality services to our clients, with the ultimate purpose of improving patient health. We do so while providing meaningful, flexible, and financially rewarding careers to our team.
I write articles here: innolitics.com/articles
You may contact me at "[email protected]"