Validation Services, Verification & Regulatory Clearances
Your Trusted Partner in Validation and Compliance
Full-Service Medical Contract Manufacturer Ensuring Compliance and Confidence in Your Product
MFG One is your trusted confidant for validation services. As a medical contract manufacturing partner, we help bridge the gap between brilliant ideas and market-ready products.
Specializing in product design and development, we provide comprehensive validation services to a diverse range of industries. With extensive knowledge of product manufacturing and the regulatory hurdles facing many industries such as pharmaceuticals and healthcare, we offer cost-effective and efficient solutions.
When you want to accelerate your journey to market without losing sleep, consider partnering with MFG One, one of the leading medical contract manufacturers in the US.
Our Validation Services
100% compliance with regulations is at the heart of successful product development. As a leading contract medical device manufacturer, we specialize in various types of validation services to ensure the quality and compliance of your product:
Design Validation Services
• Verification/Validation of Final Unit
• Verification/Validation of Software
• Packaging Design/Validation
• Risk Assessment
• Design Failure Mode and Effects Analysis (dFMEA)
Manufacturing Process Validation Services
• Process Failure Mode and Effects Analysis (pFMEA)
• Verification/Validation of Software
• Risk Assessment
Validation Services, Offerings, and Capabilities
We proudly specialize in the following components but are not limited to:
- GMP, cGMP, GLP, GAMP
- IQ/OQ/PQ
- Calibration Management
- CFR 21, Part 11 Electronic Signatures, Electronic Records Consulting
- Computer system Validation
- Design Specification
- Equipment Validation
- Facility Qualification
- FAT & Commissioning
- Final Validation Reports
- Functional Specification
- Process Validation
- Requirements Analysis
- Risk Assessment
- Site acceptance Tests (SAT)
- Software Requirements Specifications (URS)
- Standard Operating Procedures SOPs
- System Validation
- Traceability Matrices
- User Requirements Specifications (URS)
- Validation Gap Analysis
- Validation Master Plan Development
- Validation Program Management
- Vendor Qualification
- Medical Device New Product Development
- Mechanical Prototype Design
- Electrical and Software Engineering
- Engineering and Design Services
- Product Design and Development
- Prototype Development
- CFR 820 Compliance
- Design for Testing (DfT)
- ROHS (Restriction of Hazardous Substances)
Meeting Regulations: Navigate the Regulatory Landscape with Confidence
As an ISO-certified and FDA-registered medical device manufacturer, MFG One is here to ensure your product meets the stringent regulations neccessary before going to market. We have a dedicated team of regulatory experts who stay on top of the ever-evolving regulations and proactively guide you through the compliance process.
Our services include:
Regulatory
Gap
Analysis
Regulatory Documentation Preparation
Regulatory Strategy Development
Liaison with Regulatory Agencies
Contract Manufacturing Best Practices
At MFG One, quality is at the core of everything we do. We understand the critical role it plays in ensuring product safety, efficacy, and regulatory compliance. That's why we adhere to some of the highest manufacturing best practices, including:
cGMP
(Current Good Manufacturing Practices)
cGMP (Current Good Manufacturing Practices)
Our 3-Step Internal Quality Control Process
Our 3-Step Internal Quality Control Process
1. Installation Qualification (IQ): Verify equipment installation and functionality meet specifications.
2. Operational Qualification (OQ): Demonstrate process effectiveness and set optimal parameters.
3. Performance Qualification (PQ): Ensure long-term process stability and consistent product quality.
Why Choose MFG One?
At MFG One, we bring over two decades of extensive experience in validation services to ensure that your products meet the standards of quality and compliance required.
As an experienced medical device manufacturer, we have a state-of-the-art facility in the USA equipped with specialized equipment and testing labs. We provide comprehensive validation and verification services that consistently yield exceptional results, as evidenced by our proven track record.
Contact MFG One, the Trusted Name for Validation Services
At MFG One, we understand the responsibility that comes with bringing medical devices to market. That's why we offer a comprehensive suite of validation, verification, and regulatory compliance services tailored to your specific needs.
Discover the global advantage with MFG One. Whether you're in Canada, the US, the United Kingdom, Mexico, or beyond, our team is ready to assist you with your project as our commitment to excellence knows no bounds.
We’re here to serve our clients worldwide, ensuring your success is our top priority.