Your Partner for Faster, Smarter US Market Entry

FDA Medical Device Validation and Consulting Services

Get Support with Our FDA Medical Device Validation and Consulting Services

At MFG One, we simplify the process of bringing your medical device to the U.S. market with comprehensive regulatory support, compliance guidance, and expert assistance in obtaining FDA approval.

100% Clean Audit Record: MFG One has maintained clean audits for 7 consecutive years—no FDA findings and no ISO findings.
Dedicated Legal Team: Our experienced legal team is here to support you, navigating complex regulations with confidence.
Strict Compliance Standards: We help ensure your device meets FDA and ISO requirements, critical for U.S. market entry.

We guide your product through every step of FDA medical device validation and registration process, so that you can move from concept to commercialization quickly and confidently. As a global leader in medical device new product introduction, we’re here to help you enter the US market faster while maintaining the highest levels of quality and compliance.

Turnkey Solutions

We handle everything-design, validation, manufacturing, and regulatory compliance-so you only need one partner.

FDA and ISO Compliance Expertise

Our FDA medical device validation and regulatory consulting make sure your product meets all necessary standards.

Cost Efficiency

We provide high-quality services without sacrificing cost-effectiveness, keeping your project on time and within budget.

Global Reach

We serve clients both in the US and internationally.

Faster Time-to-Market

With a structured approach, we help you meet regulatory milestones faster, giving you a competitive edge in the US market.

Whether you’re in Canada, the UK, Mexico, China, India, or anywhere in the EU and Asia, we provide a clear pathway through the regulatory landscape with our FDA medical device validation and regulatory consulting services.

Bringing Your Medical Device to the US Market Faster

The US medical device market offers vast opportunities but comes with stringent regulatory demands. With MFG One, you can break into the US market faster by leveraging our medical device consulting services. As part of our validation, verification, and regulatory approval services, we guide your product through meeting all necessary requirements, helping to reduce time-to-market delays.

Why Being in the US Market Gives You the Upper Hand

Entering the US market allows your medical device to reach a vast customer base and gain credibility by meeting strict FDA standards. Our FDA medical device validation, verification, and clearance process is designed to help you bring your product to the US market while adhering to FDA guidelines, ensuring it is properly registered and approved. This sets you up for global success, as the US serves as a key gateway for international market entry.

Comprehensive Validation Services

Our validation services are thorough and tailored to meet your specific product needs, covering every step of the process to guide your product toward FDA approval.

FDA Medical Device Validation Support

MFG One specializes in guiding medical equipment through the FDA’s stringent validation process. With an in-depth knowledge of the USA's FDA process along with our medical device regulatory consulting, we can help you streamline compliance efforts from concept to final approval.

Steps: We follow detailed FDA guidelines from design verification testing through market entry, ensuring every requirement is met.
Things to Consider: FDA standards change frequently. Our team stays ahead of these shifts to help you adapt and comply quickly.
Bottlenecks: Common bottlenecks include delays in documentation and testing. We identify and address these early, keeping your project on track.

ISO 13485 Contract Manufacturer

ISO 13485 is the global standard for medical device quality management systems. MFG One provides the expertise you need to meet all your regulatory requirements.

Steps: As an ISO-certified and FDA-registered contract manufacturer, we uphold the highest standards to maintain quality and compliance throughout your product's lifecycle, from design to production.
Things to Consider: Getting your product FDA approved is critical for entering the US market. We ensure you're fully prepared to meet these stringent standards with confidence and efficiency.
Bottlenecks: Common issues include gaps in software validation and documentation. Our proactive approach tackles these before they can slow down your process.

Benefits of Partnering with MFG One for FDA Medical Device Validation and Consulting

Choosing MFG One as your validation partner in verification and validation testing offers several advantages, from expert FDA medical device validation and regulatory support to cost-efficient results:

Cost-Effectiveness: By working with a turnkey contract manufacturer in the USA, you save on costs by avoiding the need for multiple vendors. We manage everything under one roof.
Efficiency: As an FDA-registered and ISO 13485-certified contract manufacturer, our integrated approach streamlines the path to market, providing a faster and more efficient process.
Risk Reduction: We address regulatory challenges early, reducing the risk of costly delays or rework.
Full Compliance: As FDA and regulatory consultants, our expertise and legal team guide you through the compliance process, helping your product meet all requirements efficiently.

Contract Manufacturing Best Practices at MFG One

At MFG One, quality is at the core of everything we do, especially in our FDA medical device validation services. We understand the critical role it plays in maintaining 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 cGMP process, established by the FDA, guarantees that medical devices and pharmaceuticals are manufactured to the highest standards. We employ robust quality control systems at every stage of production, from raw material sourcing to final product packaging.

Our 3-Step Internal Quality Control Process

Beyond cGMP, we have established a rigorous 3-step internal process to guarantee comprehensive quality control and compliance through our contract manufacturing services:

This meticulous approach guarantees your product complies with FDA guidelines for process validation, reinforcing product safety and regulatory adherence.

#1. Installation Qualification (IQ)

Installation Qualification (IQ)

Verifying equipment installation and functionality to meet specifications.

#2. Operational Qualification (OQ

Operational Qualification (OQ

Demonstrating process effectiveness and setting optimal parameters for production.

#3. Performance Qualification (PQ)

Performance Qualification (PQ)

Maintaining long-term process stability and consistent product quality.

What to Expect with MFG One’s Validation Process

When you choose MFG One for your FDA medical device validation and regulatory support service, here’s what you can expect:

Initial Consultation: We analyze your product’s needs and develop a tailored validation strategy.
Design Integration: Our team keeps FDA guidelines in mind during the design and engineering process to avoid costly revisions.
Validation and Testing: We conduct thorough design validation to confirm that your product meets all FDA regulatory requirements.
Post-Market Support: Even after market entry, we offer aftermarket services and 3PL services to manage your product’s lifecycle.

Ready to Enter the US Market with Confidence?

If you’re looking to accelerate your medical device’s entry into the US market and achieve full FDA compliance, MFG One is your partner of choice. With global services in the US, Canada, the UK, Mexico, and beyond, we’re here to help you with our FDA medical device validation and consulting.

Contact MFG One today to learn more about how we can help you bring your product to market faster and more efficiently.