Our Process
Leaders in designing and manufacturing disposable medical devices.
Remington has a detailed, proven process for medical device manufacturing. Find out how we handle manufacturing for our customers.
Our Proven Process for Contract Manufacturing
Remington Medical has a proven process that results in successful contract manufacturing:
Establish
First, our team starts by establishing a solid relationship with you to make sure we understand your needs. Remington specializes in manufacturing handheld, disposable devices, so we talk through our in-house tool shop capabilities to give you a better understanding of how we turn your product idea into a reality with innovative manufacturing techniques. We also examine regulatory requirements that need to be met to manufacture a successful medical device.
Discovery
Next, we learn more about your existing device or your idea for a new product. We discuss product features, expected performance, a product launch timeline, and potential obstacles. This phase of our process allows us to learn more about your existing medical devices so we can understand how to help you with our manufacturing capabilities.
Research
Then, the research begins. Our team starts by reviewing your product documentation, contacting vendors of your choosing. We’ll ask you any questions we may have about your product, and design a custom manufacturing process based on your product features and end-user goals.
Scope
Once our research is complete, we provide you with a scope of work statement that includes design drawings, an assembly and packaging guide, price quote, product volume, and target price. Our scope of work also includes a team member outline that gives you details on project responsibilities for each Remington employee that has a hand in manufacturing your device. From the program manager, project engineer, and technical writer, you’re introduced to every expert dedicated to your product’s success from start to finish.
Commercialization
Next, Remington develops all the necessary documentation to begin commercializing your product. We complete tooling and fixturing details, establish a production line, and begin initial builds for testing or prototyping requirements. During the commercialization phase, our team also registers as your device’s manufacturer of record (MOR). As your MOR, Remington designs and manufactures your device on your behalf, ensuring each compliance and regulatory requirement is met along the way. From there, our dedicated launch pod team, including a program manager, project engineer, and technical assistant, take your project from initiation and commercialization to production.
Transfer
Once the commercialization process is complete, we transfer your product to production. We define and implement a unique manufacturing strategy for your medical device, solving complex problems if they arise and ensuring that your time-to-market date isn’t affected.
Product Lifecycle Management
After your product is launched, we nurture its success with our product lifecycle management services (PLM). With Remington’s PLM strategy, our team expands your device’s production as needed, transitions to your device’s next revision level when it’s time, and ensures that ongoing product quality is achieved.
At Remington, We Learn From Experience
We’re different from other medical device manufacturing companies because we have a line of superior, disposable devices. At Remington, we learn from experience, taking our own manufacturing best practices and applying them to our customer processes.
Remington Facilities
Our Headquarters
Remington has three manufacturing facilities in multiple locations to fulfill your product needs. We opened our first facility in Dunwoody, Georgia, in 1992. Remington outgrew the building after only five years, so we opened our main headquarters in Alpharetta in 1997.
Our headquarters has 21,000 square feet of production space with dedicated areas for:
- Class 8 cleanrooms
- Packaging and sterilization
- Labeling
- Distribution
Our Second Location in Georgia
By 2004, we outgrew again, so it was time to open a second location in Alpharetta, where we focus on medical device manufacturing for small to medium-sized companies. Our second location in Georgia allows us to implement other customized, in-house medical device manufacturing processes like:
Our Nearshore Facility
Remington’s most recent facility opened in the Dominican Republic in 2011. With 30,000 square feet of manufacturing space, our nearshore facility allows us to develop unique product components for a variety of medical devices without time zone constraints, delayed freight time, and IP issues.
Our Certifications
ISO 13485
As an experienced medical device manufacturer, Remington has an ISO 13485:2016 certification for our superior quality management system, certified by our notified body, the British Standards Institution, or BSI Group. Our process to manufacturing provides you with an effective solution that meets comprehensive requirements for a quality management system in the medical device industry. Our ISO 13485 certification ensures that our medical device manufacturing process is effective, we’ve met all regulatory and customer requirements, and are managing risks appropriately.
MDSAP
Remington is also Medical Device Single Audit Program (FDA MDSAP) certified. Our device audits are consolidated to one standard regulatory framework, covering five different medical device markets, including Australia, Brazil, Canada, Japan, and the United States. Our MDSAP certification promotes consistency, predictability, and transparency of regulatory programs by standardizing practices and procedures.
FDA registered medical devices must pass a rigorous test and meet critical requirements to be approved for an ISO 13485 certification or a standard FDA regulatory. In the medical device industry, receiving one certificate doesn’t inherently mean you’re approved for the other, but Remington’s medical device manufacturing process is so efficient that we meet both sets of requirements.
Benefits of Our Contract Manufacturing Services
Manufacturing a new medical device is a marathon, not a sprint. That’s why the Remington team accounts for process adjustments along the way, ensuring that your time-to-market date reaches the finish line as expected. Remington machinists receive real-time feedback when our engineers make tweaks to your process, allowing our in-house tool shop experts to adjust quickly.
With Remington taking care of every aspect of your manufacturing process, you get:
- A high-quality product
- Streamlined distribution
- Reduced shipping costs
- Lower production costs
- A single-source vendor
Contact us today to learn more about how we can help you manufacture a high-quality medical device.
Where Imagination Meets Reality
Contract manufacturing and high-quality medical tools to make your job easier. Contact Remington to see how we can improve your medical devices!
