Looking for quality products that meet or exceed all relevant certification and compliance standards? Remington Medical’s in-house manufacturing capabilities allow us to scale production up or down based on your order volume and product specification.
Medical Device Certification: U.S. and International Guidelines
When our clients initially reach out to our team about beginning production for specific devices, they inevitably ask about our process: where our facilities are, what certifications our team holds, project timelines, and more. We’ll dive into the answers to those questions in this piece and others from our FAQ series, but there’s a broad, all-encompassing goal that unites the answer to all of them: We’re always trying to make life easier for our clients.
Flexibility Sets Apart the Top U.S. Medical Device Companies
While we retain the proximity and ease-of-use of a U.S.-based medical device company, our manufacturing facilities abroad allow us to offer even more flexibility and scalability for our clients. We operate manufacturing facilities domestically and in the Dominican Republic, giving us the freedom to accommodate your orders and scale up production accordingly. It all comes down to what our customers are looking for.
What About Compliance?
When it comes to specific certifications, there’s no margin for error. Failure to comply with modern standards can result in disaster for our clients, and our goal is to always make the process as smooth and simple as possible. All Remington Medical facilities are compliant with FDA 21 CFR Part 820 and have been issued ISO 13485:2016 certificates by our notified body, the British Standards Institution or BSI Group. We also work with organizations including:
Medical Device Single Audit Program (MDSAP)
Japanese Pharmaceutical Affairs Law (JPAL)
The European Union
Among other regulatory bodies
U.S. Food and Drug Administration-grade medical devices have to undergo rigorous testing and meet specific criteria to be put into practice. At Remington Medical, we make sure every device and product we manufacture meets or exceeds all relevant standards.
What About Project Time Frames?
It all depends on what kind of product you order. Medical device manufacturers rely on Remington to deliver quality products so they can help hospitals function more efficiently and provide superior care. They choose our team because of the quick turnaround times we provide for our clients—whatever you need, we’re confident we can deliver what you’re looking for in a time frame that makes sense for you.
We Make Production Simple
Why over-complicate things when you don’t have to? At Remington Medical, our team is focused on providing you with high-quality products that align seamlessly with what you’re looking for. To get started on your project order today, reach out to our team. See for yourself what a difference it makes to work with a superior medical device manufacturing company.