Medical Device Manufacturer of Record
Your single-source medical device manufacturer of record.
When you choose Remington Medical as the manufacturer of record for your medical device, we hold ourselves accountable for every step of the manufacturing process, from prototyping to final assembly.
Years of Experience as a Medical Device Manufacturer of Record
The purpose of defining a medical device manufacturer of record is so the FDA knows where your medical device is manufactured. That way, if a product has issues in the field, like failures or complaints, the FDA knows who to audit to determine if the issue stems from the device’s design, manufacturing process, or another factor.
Remington holds several final stage manufacturer certifications. We’re ISO 13485:2016 certified for U.S. and D.R. operations, using the British Standards Institute (BSI) as a notified body. With Remington as your manufacturer of record for the FDA, you get reliable, high-quality products that comply with all regulations.
As an experienced manufacturer of record for the FDA, Remington designs and manufactures high-quality medical devices on your behalf, ensuring each compliance and regulatory requirement is met along the way. We take manufacturing seriously and hold ourselves to a high standard. If questions arise regarding your product’s manufacturing process and an audit occurs, our team of experts gladly step up to the plate and clear up any confusion, supplying the right documentation to ensure that there’s no issues with your product’s manufacturing process.
Remington makes the manufacturer of record registration process seamless. We log into the FDA portal and register as your medical device manufacturer of record. It’s as simple as that when you choose Remington.
When you partner with Remington, you don’t have to worry about working with multiple vendors for design and final assembly manufacturing. As a one-stop shop specializing in medical device manufacturing, Remington offers everything you need for a high-quality medical device in one place, holding ourselves accountable for the entire production process while maintaining our tight quality control—that’s how we prefer it.
All medical device manufacturers have FDA registration to be a MOR, but at Remington, we’ve manufactured our own line of disposable medical devices, so we understand how the FDA audit process works from a customer perspective, unlike other manufacturers who don’t have our experience entering the market.
Registering as your manufacturer of record is one seamless step of our proven process that results in a successful product for our contract manufacturing customers. Before we establish ourselves as your manufacturer of record, a few other processes must be completed. From research and prototyping to final packaging, Remington takes care of everything.
We’re known for being a detail-oriented manufacturer of record for a variety of medical devices. Read our latest case study to learn more about our innovative processes.
At Remington, we work alongside other suppliers to develop unique device components, giving you access to an approved vendor list, preventing you from choosing an unreliable supplier. With Remington, you get a reputable component supplier that has extensive material traceability and meets FDA requirements. If you have a component supplier in mind, we can also consult with and vet them as a high-quality vendor before the partnership begins.
Although our team often partners with other component suppliers, we complete the final assembly, sterilization, and packaging so that when your product is submitted to the FDA for approval, we’re considered your medical device manufacturer of record. With Remington, you don’t have to worry about regulatory and compliance issues—we assist in the process and help out with your regulatory approval journey.
We’re different from other medical device manufacturers—Remington has its own established line of devices that are manufactured from scratch at our facility. At Remington, we understand the customer perspective and take lessons learned from the FDA, using them every day to guide our customers through the process.
Contract manufacturing and high-quality medical tools to make your job easier. Contact Remington to see how we can improve your medical devices!