Quality & Certifications
Get Consistent Quality from an ISO Certified Manufacturer
At MFG One, quality isn't just an aspiration, it's our foundation. As an ISO certified manufacturer, we prioritize producing high-quality products to ensure customer satisfaction, product safety, and regulatory compliance.
Our meticulous approach consistently delivers quality, minimizes errors, and ultimately helps you launch a successful product.
MFG One's Certifications
Built-in Quality,
Every Step of the Way
Building a high-quality product is paramount for success. As an ISO certified contract manufacturer in the USA, we take a holistic approach to quality, ensuring every aspect of the manufacturing process adheres to the highest standards. Here’s how we achieve this:
ISO 13485 Certification
ISO 13485 Certification
FDA Registration
FDA Registration
cGMP Compliance
cGMP Compliance
Lean Manufacturing & 5S Methodology
Lean Manufacturing & 5S Methodology
Dedicated Quality Control Department
Dedicated Quality Control Department
Expertise in Regulatory Guidance
Apart from manufacturing excellence, we also offer comprehensive regulatory support. Our team has extensive experience in navigating various regulatory hurdles, including:
NRTL Certification
We can guide you through the process of obtaining NRTL certification, ensuring your product complies with North American safety standards.
RoHS Compliance
As an ISO certified manufacturer, we are committed to environmentally responsible practices. We’ll help you achieve compliance with RoHS (Restriction of Hazardous Substances) directives, ensuring your product meets environmental safety regulations.
FDA Submissions
Our team can assist you in preparing and submitting all necessary documentation to the FDA for a smooth and efficient approval process. Our expertise as an ISO certified contract medical device manufacturer helps streamline this process.
Beyond Quality Control: Proactive Design for Success
VAVE Services
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We'll evaluate your product design to identify areas for improvement to bring down costs without compromising performance or quality. This is all part of the value proposition we offer as an ISO certified manufacturer.
Design for Manufacturing Assembly (DFMA)
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We'll analyze your design to ensure efficient and cost-effective production, minimizing waste and production time.
Design for Excellence (DFX)
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We'll collaborate with you to refine your design for optimal performance, reliability, and manufacturability. Our expertise as an ISO certified manufacturer ensures your product achieves its full potential.
Design for Test (DFT)
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We'll develop a comprehensive test plan to identify and rectify potential issues early in the development process, saving time and resources during production.
Contact MFG One, the Leading Contract Manufacturing Company for Product Design and Development Solutions
By partnering with MFG One, an ISO certified contract manufacturing organization, you'll experience a quality-driven approach from concept to completion. Our commitment to excellence ensures that your product is meticulously designed to meet the necessary requirements to meet quality, reliability, and performance.
We offer a complete suite of contract manufacturing services, including engineering and design services, 3PL services, and more to ensure your product's success. We proudly serve national and international clients of different industries across the globe including but not limited to the USA, the United Kingdom, Canada, and Mexico.
Ready to experience the MFG One difference? Contact us today to schedule a free consultation!