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...
What Is QMSR (Quality Management System Regulation)?
If you manage quality or regulatory work for a medical device company, you have probably heard that the FDA changed its rules. The shift from the...
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...
How Manufacturing Process Controls Affect Medical Device Compliance
At MedLaunch, we see manufacturing process controls as a direct link between product quality and regulatory compliance. A strong design can still run into trouble if...
How Risk Management Activities Should Be Integrated Throughout Medical Device Development
At MedLaunch, we see proactive risk management as a core part of good medical device development. It supports better design decisions, stronger documentation, and smoother regulatory...
Common Documentation Gaps That Delay Medical Device Regulatory Submissions
At MedLaunch, we see a common pattern behind many delayed regulatory submissions. The issue is often not the product concept or the test plan. It is...