A quick look at the SaMD guidelines worldwide
You don’t need to be a major manufacturer of MedTech devices to develop medical software. And I say that for 2 reasons.
For one, smaller-sized, tech-driven companies are doing that every day. Organizations that are familiar with any operating system's planning, development, and roll-out processes. That can ensure effective development, software implementation, and efficient release for you.
Also - healthcare is one of the most regulated industries in the world. Yes, if your product runs afoul of any regulations, it can be removed from the marketplace, or you could be fined or sued by consumers. But if you learn, understand and use these rules and regulations - your software may already be on the way to help patients and users.
Here’s a look at the guidelines for developing healthcare software around the world.
SaMD in chapters // Table of Contents