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

FDA Registration Certification

ISO 13485
Certification

louisiana board of drug and device distributors logo

louisiana board of drug and device distributors Certification

Virginia Board Pharmacy

Virginia Board Pharmacy Permit

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

We operate under the rigorous guidelines of ISO 13485, specifically designed for medical contract manufacturer operations, ensuring the highest level of quality and safety for your product.
View Certification

FDA Registration

FDA Registration

Our FDA registration allows us to seamlessly navigate the complexities of medical device production, saving valuable time and resources.

cGMP Compliance

cGMP Compliance

We adhere to cGMP standards, allowing us to produce consistent quality and minimize the risk of contamination throughout the manufacturing process. This is another key aspect of our commitment to quality as an ISO certified manufacturer.

Lean Manufacturing & 5S Methodology

Lean Manufacturing & 5S Methodology

As an experienced full-service contract manufacturer, we leverage lean manufacturing principles and the 5S workplace organization system to optimize production efficiency and minimize errors.

Dedicated Quality Control Department

Dedicated Quality Control Department

Our experienced quality control team meticulously inspects every aspect of production, ensuring your product meets all specifications.

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

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)

We’ll analyze your design to ensure efficient and cost-effective production, minimizing waste and production time.

Design for Excellence (DFX)

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)

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!