Hoveround ups certification
SARASOTA, Fla. – Hoveround has a new ISO certification that puts it in line with the U.S. Food and Drug Administration’s good manufacturer practices (GMP) and paves the way for the company to be able to sell products overseas.
Hoveround has had International Standard for Organization (ISO) 9001 certification since 1997, said CEO Tom Kruse. Adding ISO 13485 certification “takes us to another level,” he said.
“The 13485 is really pretty amazing as it is completely aligned with the FDA’s GMP and that’s an international standard,” he said. “So, if we opted to take products overseas, we would be compliant.”
That’s a move Hoveround is eyeing in the mid-term, Kruse said.
Meanwhile, the new certification helps protect Hoveround from the increased FDA and regulatory scrutiny medical device manufacturers are experiencing. ISO certification helps ensure products are made and processes are completed the right way each time, Kruse said. It also gives guidelines for changing processes, he said.
“ISO is a process, so you say this is what we want to do, this is our expectation, this is our measurement, and it gives you a process,” Kruse explained.
Hoveround chose to secure a second ISO certification because of the nuanced differences between the two, Kruse said.