Healthcare Industry News: CustoMED
News Release - July 23, 2007
National Standards Authority of Ireland Redefines the Medical Device Approval Process
NASHUA, N.H.--(HSMN NewsFeed)--The National Standards Authority of Ireland (NSAI) is redefining the medical device certification industry by offering North America's only time-to-market certification service for medical devices."For too long, certification bodies have been a roadblock for medical device manufacturers," says Kevin D. Mullaney, President and CEO of NSAI. "You only have to speak with a few industry representatives to learn that no one in the medical device manufacturing field is happy with the service provided by their notified bodies. Product time-to-market is the key to success for medical device manufacturers, however poor response and project completion times by regulatory bodies can add months to a product launch. But now NSAI has restructured and refocused its efforts on medical device certification. All of our employees are focused on one mission: to provide medical device customers with fast turn around times for rapid-response medical device certification."
Mullaney says the number of regulatory bodies providing CE Marking, CMDCAS and ISO 13485 and 14971 certifications for medical device manufacturers is relatively limited. And because these services are typically a small part of these regulatory bodies' larger overall portfolio of services, the medical device manufacturers end up being the small fish in a large pond. When there are service issues, the regulatory bodies fix the problem and forget about service until the next crisis arises. This results in the large fluctuation in performance that the industry has become acCustoMED to.
"NSAI is going to turn the regulatory industry on its head with the only true time-to-market service out there for medical device manufacturers," says Mullaney. "By concentrating solely on the medical device directives, we will be able to give manufactures a totally new experience when it comes to working with a regulatory body. Our number one goal is to get our client's products quickly to market and the changes we've undergone at NSAI will allow us to deliver on this promise."
For over 50 years, the National Standards Authority of Ireland has been offering a full range of services relating to Management Systems Standards and Certification Services throughout the world. The company provides medical device manufacturers with CE markings, CMDCAS and ISO 13485 and 14971 certifications. For more information visit www.nasiinc.com or call 603-882-4412.
Source: National Standards Authority of Ireland
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