Wherever you are in your product development lifecycle,
Sterling can help.
Our team of medical device regulatory, clinical, and quality assurance experts will help you address any regulatory challenge—or, better yet, minimize those challenges in the first place. We’ll help you:
Ensuring your device complies with the strict regulations mandated across the medical device industry is not your area of expertise—but it is ours. Turn that burden over to us.
For more information, fill out the contact form.
Regulators want to see a very specific design process, strong quality control, robust risk management and an airtight submission package. At Sterling Medical Devices, the FDA has accepted our thorough Design History Files (DHF) every time, showing that we have tried to think of every possible scenario through software verification and medical device testing. We ensure that the medical device software and medical device hardware are doing what they are supposed to be doing and designed to do.
August 9, 2022
February 18, 2021
April 5, 2023