What to Expect From FDA Registered Medical Device Manufacturers
FDA registered medical device manufacturers strive to deliver high-quality, reliable devices to the healthcare industry. While meeting FDA standards is a requirement, complying with international standards brings medical device manufacturers a step above the rest.
Quality Products, Every Time
At Remington Medical, quality is the key to manufacturing. We ensure that each one of our FDA registered medical devices meets the standards of practitioners across the globe. With more than 25 years of medical manufacturing experience, we strive to consistently deliver reliable, high-quality products that customers can depend on.
ISO 13485 Certification
Remington Medical is an FDA registered facility that has an ISO 13485 certification—an international standard for quality management given to us by our notified body, the British Standards Institution, or BSI Group. Our manufacturing process demonstrates an effective solution that meets comprehensive requirements for a quality management system in the medical device industry. The certification aligns our company management system with requirements of the FDA’s QSR and international regulatory requirements, as well as provides a framework for compliance to various regulatory and customer requirements.
In summary, our ISO 13485 certification ensures that our medical device manufacturing process is effective, we’ve met all regulatory and customer requirements, and we’re managing risks appropriately.
We are also Medical Device Single Audit Program (FDA MDSAP) certified, which means our device audits are consolidated to one standard regulatory framework that covers five different medical device markets, including Australia, Brazil, Canada, Japan, and the United States. The certification promotes consistency, predictability, and transparency of regulatory programs by standardizing practices and procedures.
FDA registered medical devices must undergo meticulous testing and meet critical requirements in order to be approved for either an ISO 13485 certification or a standard FDA regulatory. Having one certification doesn’t inherently mean you’re approved for the other, but our manufacturing process and approved medical devices are so efficient that we meet both sets of requirements.
Benefits of Our FDA Registered Medical Devices
At Remington Medical, we’re dedicated to quality and control. That’s why we manufacture all our medical devices in-house, ensuring that a superior product is developed and delivered to practitioners every time. From our drainage bags, decanters, and locking syringes to our cables, needles, and guides, all products manufactured by Remington Medical paint the picture of quality.
While some medical devices are a luxury, ours are a necessity. We manufacture FDA registered medical devices that can either help rule out conditions or make a diagnosis and ultimately save someone’s life.
Improved Locking Syringes Quality Control
Our locking syringes lock in at 6 cc’s and hold vacuum for aspiration biopsy procedures—operations that involve taking a sample of abnormal tissue or body fluid in order to rule out life-threatening diseases, such as cancer.
Single-Use Assembly Cables Save Hassle
Remington Medical also manufactures assembly cables. Reusable cables don’t last forever, but by choosing a single-use cable from us you can save on the cost of sterilization and ensure a hassle-free inventory check.
Improved Disposable Decanter Bags
Decanter bags are a necessity in the medical industry. That’s why we manufacture high-quality, spiked bag decanters specifically for the transfer of sterile fluids. Our bags include two caps and choice of angle options for ease of dispensing.
We also offer disposable drainage bags. Our drainage bags hold up to 600 ml and are ideal for severe abscess draining, biliary draining, and nephrostomy.
One-of-a-Kind Biopsy Needles
Quality needles don’t have to come at a high cost. We’ve developed and manufactured our own biopsy needles so you can still use your preferred biopsy gun. Our needles give you more options at a better cost and configure with most guns on the market. When you use Remington Medical’s biopsy needles with your preferred brand of biopsy gun, your patients will benefit from accurately fired needles and easy sample collection. Just like our cables, Remington Medical manufactured needles deliver on the commitment to provide reliable, high-quality medical devices.
Our soft tissue biopsy needles are essential for obtaining core tissue samples for cytological evaluation. These MLL-Style needles can provide large and fully intact specimens.
We also manufacture a variety of other needles that do extraordinary things. From bone marrow biopsy to breast cancer localization, our needles can help you discover underlying conditions and change your patients’ lives for the better.
Find Out More About Our High-Quality Products Today
At Remington Medical, we strive to bring you the best FDA registered medical devices on the market. We triple check each one of our products in-house to ensure you receive a high-quality device every time.