US Market Access for Medical Devices and IVDs

View our U.S. Market Access services

We work with clients to solve their biggest challenges in regulatory affairs, quality assurance, and device risk mitigation.

Certificate of Free Sale (CFS) for Medical Device Exports

Emergo helps medical device companies secure Certificate of Free Sale (CFS) for medical device exports to countries around the world.

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FDA Q-Sub Consulting and Pre-Sub Guidance for Medical Devices

Our US consulting team has extensive experience with the FDA Q-Sub process for medical devices. We can assist you with this critical step as part of the FDA clearance process.

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FDA QSR Audits for Medical Device and IVD Companies

Learn how we can assist medical device and IVD companies in complying with QSR audits and implementing a quality management system under current GMP standards.

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FDA QSR Consulting (21 CFR 820) for Medical Device Manufacturers

Emergo by UL offers FDA QSR consulting for medical device and IVD companies to help support successful 21 CFR Part 820 implementation and compliance.

FDA Submission Consulting for Medical Devices and In Vitro Diagnostics (IVDs)

FDA submission consulting services for medical device and IVD companies. Get help with US FDA registration from Emergo by UL.

ISO 13485:2016 Consulting and Gap Analysis

ISO 13485:2016 is coming! Let Emergo help you transition from ISO 13485:2003 or ISO 13485:2012. Local offices throughout the US, Canada, Europe and Asia.

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ISO 14971 Risk Management Consulting for Medical Device Companies

ANSWERED ON THIS PAGE:

What does ISO 14971 require?
How do I implement ISO 14971?
How do I apply the risk management system and concepts to my product?

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Local Authorized Representative for Medical Device Manufacturers

Emergo by UL can act as an independent, local authorized regulatory representative for medical device and IVD manufacturers seeking global market access.

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MDSAP Compliance: Medical Device Single Audit Program Consulting

Learn how using our internal and gap audit services to meet MDSAP specifications can improve your global market access efforts for medical devices and IVDs.

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Medical Device Post-market Surveillance

Regulatory compliance doesn’t end when your device goes to market. We design compliance solutions informed by a life-cycle approach to device safety and effectiveness.

Medical Device UDI (Unique Device Identification) Consulting and Training

ANSWERED ON THIS PAGE:

How does the US FDA UDI system work?
When must we comply with UDI system requirements?
Which device classifications need to comply with UDI requirements?

Minimize Errors that Delay Regulatory Approval

RAMS® Smart Builder walks you through regulatory documentation for Brazil’s Registro Route, Mexico Equivalency and Standard Route, US FDA 510(k), and Europe’s MDD, MDR, and IVDR.

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United States

Certificate of Free Sale (CFS) for Medical Device Exports

FDA Q-Sub Consulting and Pre-Sub Guidance for Medical Devices

FDA QSR Audits for Medical Device and IVD Companies

FDA QSR Consulting (21 CFR 820) for Medical Device Manufacturers

FDA Submission Consulting for Medical Devices and In Vitro Diagnostics (IVDs)

ISO 13485:2016 Consulting and Gap Analysis

ISO 14971 Risk Management Consulting for Medical Device Companies

Local Authorized Representative for Medical Device Manufacturers

MDSAP Compliance: Medical Device Single Audit Program Consulting

Medical Device Post-market Surveillance

Medical Device UDI (Unique Device Identification) Consulting and Training

Minimize Errors that Delay Regulatory Approval

Request information from our specialists

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United States

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Certificate of Free Sale (CFS) for Medical Device Exports

FDA Q-Sub Consulting and Pre-Sub Guidance for Medical Devices

FDA QSR Audits for Medical Device and IVD Companies

FDA QSR Consulting (21 CFR 820) for Medical Device Manufacturers

FDA Submission Consulting for Medical Devices and In Vitro Diagnostics (IVDs)

ISO 13485:2016 Consulting and Gap Analysis

ISO 14971 Risk Management Consulting for Medical Device Companies

Local Authorized Representative for Medical Device Manufacturers

MDSAP Compliance: Medical Device Single Audit Program Consulting

Medical Device Post-market Surveillance

Medical Device UDI (Unique Device Identification) Consulting and Training

Minimize Errors that Delay Regulatory Approval

Request information from our specialists

Thank you! We've received your request.