Medical Device Consulting
Welcome to Sequence Group, where we specialize in providing expert guidance and support in the area of device regulatory consulting and medical device design and development.
Device Consulting
Navigating regulatory challenges are at the heart of our approach. We bring decades of expertise to every engagement, helping medical device companies bring safe, effective products to market.
Learn MoreQUALIFIED SPECIALISTS
Experienced in all areas of device design and development, from device inception to regulatory submission.
INDIVIDUAL APPROACH
Our consultants are experienced in all aspects of the development life cycle and can guide you through.
GREAT EXPERIENCE
We work with each client individually to ensure the project goals are met and the objectives are achieved.
FRIENDLY CUSTOMER SERVICE
We take the complexity and headache out of the design process. Contact us today to see what we can do for you.
What we do
Market Research
We help you evaluate your device and with market research and determine the appropriate pathway forward.
Project Planning
We bring a straight forward approach to the development planning process to help ensure your project is a success.
Development Lifecycle
We can guide you through each step of the process, including final device preparation and submission.
Regulatory Consulting
Full consulting and guidance is offered through the entire regulatory submission process, including 510k and EU MDR.
Post Market
In addition to guidance on the development process, we provide post market support to help ensure your organization stays compliant.
Proven Strategy
Take the guess work out of the design process and follow our proven development steps to ensure your device makes it to market.
US Agent Services
Foreign manufacturers must designate a US Agent for FDA registration. Sequence Group serves as your official FDA-designated US Agent, handling all correspondence and compliance.
20+ years of experience
What our clients say
Sequence Group performed the full software validation on our QMS and helped bridge the gap to bring us to the next level.
Thanks to Sequence Group, we were able to develop our Design History File that helped us launch a successful product.
Sequence Group's regulatory consulting guidance was a tremendous help during the initial growth phase of our organization.
Sequence Group was vital in providing guidance and support during the design and development process.
We provide solutions to the design process
Take the guess work out of the process and consult with us for a proven pathway forward.
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