Do Wellness Devices Need FDA Approval?
Wellness devices do not require FDA approval or premarket clearance if they promote general wellness or healthy activity and present a low risk to users without...
What Documentation Is Needed for IEC 62304 Compliance?
Building medical device software comes with a clear set of expectations. IEC 62304 defines the software lifecycle processes you need to follow, and most of those...
Key Differences Between 510(k), De Novo, and PMA Regulatory Pathways
Selecting the right FDA regulatory pathway can shape your product timeline, budget, data plan, and market strategy from day one. At MedLaunch, we advise teams to...
Preparing for the FDA’s 2026 Human Factors Requirements
What the May 2026 FDA human factors guidance means for your medical device 510(k) submission The Food and Drug Administration issued an updated human factors guidance...
Beyond the 510(k): Why Med-Tech Launches Stall Without Strategic Alignment
In the med-tech sector, a dangerous misconception persists: that obtaining an FDA clearance letter is the equivalent of a market success guarantee. As we navigate the...
Understanding IEC and ISO Standards for Medical Device Compliance
For medical device developers, IEC and ISO standards are more than just items on a checklist; they are the fundamental building blocks of safety, performance, and...