Formly provides software that assists with medical device certification compliance, enabling the creation of ISO 13485 compliant Quality Management Systems and facilitating documentation and regulatory processes.

FormlyAI

Formly

FormlyAI | 148 followers on LinkedIn. Medical device conformity made easy | FormlyAI is medical device compliance made easy. Our AI powered software ensures medical device certification that is fast, affordable, and tailored to your needs. Reach out to us if you are interested in learning more!

Frontend Developer | JavaScript | React

Ingrid Amaral

CEO & Co-Founder at FormlyAI | Medtech certification for startups made easy | ex-FDA

Spencer Todd

Operations Director at Silicon Allee

Florin- Catalin Chici

I'm happy to announce that our friends at LipoCheck just successfully certified their software medical device LipoAlly under MDR - all by using our FormlyAI software! You can learn more about LipoAlly here: https://lnkd.in/ewVpG3Wn The LipoAlly app is a 12-month digital care model that supports patients with lipedema through guideline-compliant content and methods of lipedema therapy and provides assistance for self-help. This includes information about the disease lipedema, treatment options, applications of those methods, and information on the right contact persons for help. Shout out to Anina L. for all her hard work leading the charge for their quality management system and technical documentation. Excited to see how LipoAlly changes the lives of people with Lipodema everywhere. If you're interested in trying our software for free, send me a message or sign up for our free trial on our website. https://www.formly.ai/

Check out our post on Product Hunt! 🚨 We appreciate any upvotes and definitely drop a comment on what you like or what to see from us. https://lnkd.in/esei2UtB

Excited to be part of MedTech Malta this year!

🚨❗ New blog alert❗ 🚨 We break down the Corrective and Preventive Action (CAPA) process - something every medical device manufacturer needs to know if anything goes wrong with your product. Learn what a CAPA is, when to initiate one, and how to carry a CAPA out successfully so you stay compliant. Plus, we give you a FREE CAPA checklist you can download and use. Check it out! https://lnkd.in/eVny66Ch

👏🏽 We are pleased to welcome FormlyAI to the MedTech World #StartupsEcosystem at MedTech Malta 2024! 🥇 Startups use Formly to handle their EU medical device compliance. AI backed documentation writing and automated regulatory roadmap tracking that gets you to market on budget. Learn more about theme here: https://www.formly.ai/ ✨ Network with leaders like Formly AI in #Valletta , #Malta , from the 6th - 8th Nov, at the historic Mediterranean Conference Centre , where healthcare innovation meets centuries of history. 🌍 🔔 Want to join our Startups ecosystem? Tickets are running out. https://lnkd.in/eFTpSrcz Don't say we didn't give you a heads-up. ✨Supported by: Lifeblood , Malta Enterprise , VisitMalta Incentives & Meetings , Malta Digital Innovation Authority .

MedTech World

The AI act isn't as scary for your product as everyone says it is. We go into detail on why in our new blog post. Don't want to get burned out by details? We have a FAQ and a TL;DR for you all at the end. https://lnkd.in/ePADsT87

Post-market surveillance - you don't need to worry about it until your device is on the market right? Wrong. You should have your post-market surveillance processes in place before even put a CE mark on your device. Read all about what post-market surveillance is and what EU requires for medical device startups in our new blog post. https://lnkd.in/ezPDfcVr

Ever wondered what "CE" stands for in the medical field? CE is an abbreviation of "conformité européenne" which equates to European conformity. CE marking indicates that a product has been assessed and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. CE marking is especially important for medical devices which must meet a high regulatory standard before being allowed on the market. Enjoy the💡 "Pitch of the Day", your daily dose of healthcare innovations, that we will share on a daily basis here between May, 1st - 31st. (13) Only 22 days left - May, 13th 2024 FormlyAI Dr. Spencer Todd FormlyAI is on a mission to make the #medical device market accessible for startups across the world by making #CE marking easy. The company has built a #software that makes #MDR #compliance feel second nature so that device certification is straightforward with no uncertainty. FormlyAI's #solutions and #support help all medical device companies achieve #medical #device #certification in the #EU and beyond. Join now 👉 https://lnkd.in/ePSTmH-c

health.tech conference

We are excited to announce we will be at DMEA in Berlin from April 8-11. Visit us in the Startup Area in Hall 5.2! At the booth we will: -> Have our Device Classification Tool set up using our FormlyAI system. Come give it a try for free! -> Scheduling for a free regulatory strategy session with our CEO Spencer Todd, Ph.D. -> Demonstrations of our FormlyAI software. Stop by and see us!

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