ISO 13485 is a necessary certification for medical device manufacturers.
It proves that you have a quality manufacturing process and the management
standards in place to maintain high quality. ISO 13485 certification is
the first step towards achieving compliance with European, Canadian and
other regulatory requirements for medical device manufacturers.
Simply put, if you want to sell your product globally, you need to be
ISO 13485 certified.
NSAI is a Notified Body that specializes in medical device certifications.
We’re committed, responsive and ready to help your company achieve
ISO 13485 certification. Our support team manages the various aspects of
the certification process so that you don't have to, resulting in faster
turn-around times, open communications, increased efficiency, and your product
in the market sooner. In short, we deliver.
When time is of the essence, choose the National Standards Authority of