Ultralight

💥 We're growing our engineering team! Ultralight is looking to chat with a few exceptional full-stack software engineers who *also* have an appetite for true product ownership at a fast-paced startup. This role is based in NYC and will collaborate directly with our co-founder & CTO Shiv Ghai. Why Ultralight? We're unlocking the true potential for medtech innovation. The $500B medical device industry is dramatically evolving, from AI-augmented diagnostics to advanced robotic surgery systems to brain-computer interfaces. The increasing complexity of products and regulation demands much better tooling, which you'll be at the forefront of building. 👋 Interested? Apply here: https://lnkd.in/eMnxEGkR #hiring #jobs #softwareengineer #medtech #saas

Design controls can rank fairly high on the list of things that medtech engineers dread, alongside recurring meetings and sales teams that overpromise product delivery timelines. What we've learned is that this dread is due to 1) a lack of understanding, and 2) terrible tooling. We wrote a simple and concise Design Controls 101 for medtech product teams. Check it out & reach out if you'd like help streamlining your design control processes. https://lnkd.in/e6-8bH_7 #designcontrol #medicaldevice #medtech #requirementsmanagement

Building medtech software? Ultralight has cooked up something special for you! Most SaMD / SiMD teams we meet wish they could release faster but are bottlenecked by the volume of documentation activities required by regulation. We wrote about our new Documentation-in-Code approach which embeds directly into software engineering tools to automatically generate necessary documentation, enabling your software team to operate with velocity while giving your quality team peace of mind. Check it out & reach out if you'd like to dramatically improve your regulated software release cycles. https://lnkd.in/eMrS7b_J #medicaldevice #medtech #SaMD #SiMD #iec62304

It's no surprise that the risk of medical device software is top of mind for hackers and regulators. The FDA now requires teams to implement an extra set of precautions, like providing machine readable SBOMs and vulnerability reports. This has caused its fair share of industry confusion, so Ultralight's co-founder & CTO Shiv Ghai wrote a summary explainer which highlights practical steps that organizations can take to improve their cybersecurity risk posture ASAP. If you're building FDA-regulated software, check it out: https://lnkd.in/emm5vC6s #medicaldevice #medtech #cybersecurity #SBOM #SaMD #SiMD

When should we hire our first Head of Quality? What kind of skillset should we look for? Do they need experience with our product type? These are common questions we hear from medical device startups. The first Head of Quality is such a critical hire for product, regulatory, and commercial success. Yet we often see startups inadequately design the recruiting process and get this hire wrong. So we decided to write a post to cover what makes a great Head of Quality and when to hire one. https://lnkd.in/eMx9xZkR #medicaldevice #medtech #qualitymanagement #qms #hiring

Amidst hundreds of consensus standards that the FDA recognizes, from biocompatibility to electrical safety, the challenge for medical device manufacturers isn't just to innovate but to navigate a labyrinth of compliance while doing so. While Ultralight already helps teams with quality & requirements management, we decided to build an all-in-one compliance management hub which helps teams quickly get compliant with any standard. If you need help conforming to a particular FDA consensus standard, reach out! We're currently offering limited trial access and free compliance checklist templates to a small cohort of early adopters. https://lnkd.in/e6sQbukg #medicaldevice #medtech #qualitymanagement #compliance

Medical device teams often struggle with parsing through the constant stream of regulatory information that may be relevant to them. So we just released two AI-powered tools that anyone in the medtech industry can use. Best of all--they're absolutely free to use. 1. Ultralight Insights: A monthly email newsletter of the latest FDA 510(k) summaries, adverse events, and more filtered by just the device types you care about. 2. Predicate Device Search: A simple search tool in which you can input your device description and we'll analyze the vast FDA 510(k) library to recommend likely predicate devices. You can also use this to refine your regulatory strategy or keep tabs on competitive solutions. To test them out, see here: https://lnkd.in/gixYAgYs #medicaldevice #medtech #fda #510k #regulatoryaffairs #qualitymanagement