Regulatory
Committed to quality and meeting medical device regulatory standards
In the medical device industry, quality is crucial. That’s why Remington Medical continually strives to deliver the most reliable, high-quality devices that comply with regulatory standards.
30+
Years of experience producing high-quality medical devices.
Our Medical Device Quality Standard
At Remington, we’re committed to manufacturing quality, disposable medical devices by complying with FDA regulatory and ISO standards. In the pharmaceutical industry, standards and requirements are constantly changing and improving, but we never falter. Our team is committed to adapting quickly and efficiently to FDA and ISO standard improvements, ensuring that every device we manufacture in our product line and for our customers through our contract manufacturing services is safe and effective.
ISO 13485: A Medical Device Quality Management System Standard
The ISO 13485 is a medical device quality management system standard that demonstrates requirements for a quality management system specific to the medical device manufacturing industry.
ISO standards are reviewed every five years to determine if a revision is required to keep the certification current and relevant for the medical industry. The standards were revised in 2016, and the current certification known as ISO 13485:2016 is designed to respond to the current quality management system best practices like changes in technology and regulatory requirements and expectations.
The newest version of ISO has improved our emphasis on risk management, risk-based decision making, and changes associated with increased regulatory requirements for the supply chain.
MDSAP
We’re 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
- The U.S.
Our MDSAP 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 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 Remington’s manufacturing process and approved medical devices are so efficient that we meet both sets of requirements.
Ensuring the Highest Medical Device Quality Since the Beginning
Remington has more than 30 years of experience in designing and manufacturing high-quality medical devices. We’ve been committed to quality since the beginning.
Benefits of ISO 13485, A Medical Device Quality Standard
ISO 13485 helps us improve our performance by providing repeatable steps to meet manufacturing goals and objectives, creating an organized culture that proactively engages in a continuous cycle of self-evaluation, correction, and operation improvements.
ISO 13485 heightens our team’s awareness, leadership, and commitment, resulting in:
- Use of more efficient resources
- Improved financial performance for us and our customers
- Increased service and product consistency
- Boosted customer value
- Improved risk management and protection of people and the environment
Our Contract Manufacturing Services
At Remington, we know that manufacturing a new medical device for our customers is a marathon, not a sprint. That’s why we account for process adjustments throughout the regulatory journey, ensuring that your time-to-market date reaches the finish line as expected.
When you you partner with us to provide you with contract manufacturing services, you get:
- A high-quality product
- Streamlined distribution
- Reduced shipping costs
- Lower production costs
- A single-source vendor
At Remington, we provide a competitive advantage for our customers by getting involved early in the product development cycle and taking it through to completion. It’s common for other companies to outsource engineering and manufacturing to lower total production costs and free up financial resources, but by offering all of these services under one roof, our team offers superior customer service and rapid turnaround times. We’re known for helping you along the way with every step, from prototyping and manufacturing to managed sterilization and packaging.
Never Sacrificing Medical Device Quality
Remington is an FDA registered facility that has an ISO 13485:2016 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 medical device quality management system in the industry. The certification aligns our company management system with requirements of the FDA’s QSR and international regulatory requirements and provides a framework for compliance to various regulatory and customer requirements.
With our ISO 13485:2016 certification, our team ensures our manufacturing process is effective, we’ve met all regulatory and customer requirements, and we’re managing risks appropriately. Contact us today to learn more about how we can help you manufacture your next 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!
