What Our Medical Device Certifications Mean
The medical device industry, like any healthcare field, is thoroughly regulated. That means in order to do business successfully and to provide high-quality medical devices, organizations need to hold a wide variety of certifications.
We decided to unpack some of our most prominent certifications, so you know exactly what they mean.
ISO 13485:2016 CERTIFIED
If you’ve browsed our site, you’ve probably noticed that we’re an ISO 13485:2016 certified medical device manufacturer. That means we pass the strict standards for quality management systems used in the manufacturing of medical devices.
Our team has to continually show that we are monitoring and correcting any quality issues that may arise. By having this certification, we also show that we continually meet customer expectations and industry requirements.
FDA REGISTERED MEDICAL DEVICE MANUFACTURER
MediSurge is an FDA registered medical device manufacturer. Every year, we register our organization and devices with the FDA. By doing so, we’re ensuring that we comply with industry standards and FDA regulations.
These regulations help us to provide high-quality medical devices and at the same time to ensure that the products we create meet strict FDA standards.
JAPANESE FOREIGN MEDICAL DEVICE MANUFACTURER CERTIFICATE
In addition to being FDA registered, MediSurge is also a certified Foreign Medical Device Manufacturer in Japan. This means we have registered with the Japanese Ministry of Health, Labor and Welfare (MHLW) and that we’ve exceeded their requirements.
By doing so, MediSurge is cleared to import medical devices to Japan, although these may need to go through more screening before they can reach the market. We’ve also done business overseas in many other countries. While we’re registered in Japan, MediSurge has the capabilities to expand on an international level to provide medical devices when and where they’re needed.
Are you ready to work with a team that has proven its capabilities time and time again? Reach out to us. We’d love to work with you.