Medical Devices - Global RA Support
The QNR team has many years experience working with agencies, certification body and third parties, supporting compliance activities, device registrations and approvals.
Our QNR consultants support device manufacturers throughout the device
life cycle with a global scope.
Global RA Support and
Customized Plans
With global scope and covering the complete life cycle, the QNR team provides customized service packages for your business.
With the QNR team, your business will have a wealth of experience on its side. For over 20 years, the QNR team has supported global regulatory affairs activities for major global device manufactures, supporting the complete device life cycle.
Whether your regulatory compliance need is for the US, Canada, the European Union (CE Marking), or any other global market, please feel free to contact the QNR team. A QNR consultant will review your business needs, discuss our services and/or solutions, and provide a customized statement of work (SOW) as needed.
To give you a better understanding of QNR's customized services, a sampling of various services that QNR has provided to clients is included below.
​Global RA Support - From Start to Approval (and Beyond)
QNR Support - The Complete Lifecycle
The QNR team has many years of experience supporting submissions to government agencies and other third parties globally, and has served as front room support for many agency and certification body reviews. With QNR, your business will have a wealth of experience on its side.
Below is a sampling of some of the submissions and related activities the QNR team can support for your business:
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United States (FDA): 510(k) submissions, recall / field correction reporting, FDA inspection support, deficiency remediation and responses, Establishment registration and listing creation and renewal, Unique Device Identification (UDI) support;
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European Union (Notified Bodies, Competent Authorities): Significant and non-significant change notifications, dossier amendments, technical review support;
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Canada (Health Canada): Amendments (including fax back), annual renewals, MDSAP compliance and support, recall / field correction reporting, device license and importer support.
QNR Support - A Global Footprint
In addition, the QNR team has supported new product introductions, agency submissions, registrations and renewals in many markets globally. A sampling of the additional markets the team has supported is highlighted below:
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China (MNPA);
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South Korea (KFDA);
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Australia (TGA);
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Taiwan (TFDA, including QSD support);
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Brazil (ANVISA, INMETRO);
RA support is full scope and may include the following activities based on business need:
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Global strategy preparation, assessment, and execution;
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Collaboration with in-country affiliates for document preparation and submission;
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Working directly with in-country agencies and certification bodies for license and/or certificate approval.
The QNR team can support your global project activities from start to approval (and beyond).
Customized Services: Meeting Your Unique Business Needs
Based on the specific circumstances of your business, the QNR team can draft a customized Statement of Work (SOW) as needed. Please feel free to contact us with questions, or visit our Terms and Conditions page for further details.
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Benefits:
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Standard packages are for specific services and are limited. We can be very flexible with custom plans and give customers exactly what they want. All the standard services can be included in custom plans.
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The Statement of Work (SOW) format allows us to frame and describe the activities in whatever level of detail needed to meet your specific needs.
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Customers can work with us on an ongoing basis per the SOW and we will invoice them monthly. It's easy to change scope with fewer hassles.
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If multiple projects / activities are in process, we can also draft a master service agreement for better tracking.
Please reference the Terms and Conditions section of the QNR website for further details.