How Does IEC 60601 Fit Into an FDA Submission Strategy?
IEC 60601 plays a central role in your FDA submission strategy for any device with electrical or electronic parts. The FDA recognizes IEC 60601 as a...
What FDA Rules Apply to Remote Patient Monitoring (RPM) Devices?
Remote patient monitoring lets clinicians track a patient's health data outside the traditional clinic, from heart rate and glucose levels to blood pressure and oxygen saturation....
How Do You Know If Your Medical Device Is Ready for FDA 510(k) Submission?
You have spent months on design, testing, and documentation. Now comes the hard question: is your device actually ready to file? For Quality Assurance managers and...
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 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...
The R&D Force Multiplier: Shifting Cybersecurity from an Innovation “Tax” to a Strategic Market Asset
To a medical device product development leader, "cybersecurity" often sounds like a black hole for your R&D budget, a tax on innovation that doesn't add a...