Generated by All in One SEO v5.0.1.1, this is an llms.txt file, used by LLMs to index the site. # Melvin Tan The Strange Developer. ## Sitemaps - [XML Sitemap](https://innershell.ca/sitemap.xml): Contains all public & indexable URLs for this website. ## Posts - [Blog](https://innershell.ca/blog/) - [The ultimate list of FDA regulations and guidelines for software medical device engineering and 510(k) clearance.](https://innershell.ca/2021/10/25/the-ultimate-list-of-fda-regulations-and-guidelines-for-software-medical-device-engineering-and-510k-clearance/) - The FDA publishes clear regulations and guidance to manufacturers for developing and marketing their regulated medical device. But if you don't know what is out there or where to look, it can be extremely overwhelming. I wrote this article to give you an easy step-by-step walkthrough of the FDA process. By following this guide, you'll - [How blockchain could change the real-estate industry.](https://innershell.ca/2018/07/28/how-blockchain-could-change-the-real-estate-industry/) - Purchase a house recently? I did ... and it was a painful 4-weeks long process. But why? Real-estate transactions today are slow, archaic, expensive, and risky. Blockchain could revolutionize this by modernizing data sharing, improving trust, reducing transaction time, and reducing overall cost. My home purchase took 4 weeks to complete the transaction because I - [How to determine if your software is an FDA regulated medical device.](https://innershell.ca/2021/11/20/how-to-determine-if-your-software-is-an-fda-regulated-medical-device/) - Developing a health app for mobile phones? Then you're probably wondering if your app is a regulated medical device. Same question if you're developing any computer software being used in a healthcare setting. I've got good news for you. Not all medical software is an FDA regulated medical device. Software as a Medical Device (SAMD) ## Pages - [Home](https://innershell.ca/) - The Strange Developer. - [About Me](https://innershell.ca/about/) - Product Management Director | Healthcare | 22+ Years Experience https://www.linkedin.com/in/tanmelvin/​ About Me I have worked at HAEMONETICS for 22+ years and have launched five FDA 510(k) approved software during my tenure, took a software business from 10% to 80% market share, hold multiple provisional patents, and recognized throughout the plasma industry as a key opinion - [Contact Me](https://innershell.ca/contact-me/) - I am always open to connecting with new people. Please use this contact form to start a dialog. Your name (required) Your email (required) Subject (required) Message (required) - [Portfolio](https://innershell.ca/portfolio/) - Software & Design My Work Glass RPN Calculator Try It Stylish web-based implementation of Hewlett Packard’s HP48/48G engineering calculator using Reverse Polish Notation (RPN). PWA HTML5 / CSS 3 / JavaScript (ES6) Sony TV Remote Try It Skeuomorphic web-based implementation of a Sony TV remote for controlling an IP-based Sony Bravia TV in a local ## Categories - [Technology](https://innershell.ca/category/technology/) - [Regulatory](https://innershell.ca/category/regulatory/) ## Tags - [510(k)](https://innershell.ca/tag/510k/) - [blockchain](https://innershell.ca/tag/blockchain/) - [innovation](https://innershell.ca/tag/innovation/) - [smart contract](https://innershell.ca/tag/smart-contract/) - [nft](https://innershell.ca/tag/nft/) - [fda](https://innershell.ca/tag/fda/)