Device Consulting
With a team of highly experienced professionals and a deep understanding of the latest developments in medical device software, AI, and cutting-edge device technology, we are dedicated to helping our clients navigate the complex and ever-changing landscape of regulation and product design.
Our goal is to help our clients bring innovative and effective medical devices to market as efficiently and effectively as possible, through strategic regulatory submissions and cutting-edge design and development solutions. We are committed to delivering exceptional service and results to all of our clients, and we look forward to the opportunity to partner with you on your next project.
Navigating regulatory challenges are at the heart of our approach.
Qualified Specialists
Experienced in all areas of device design and development, from device inception to regulatory submissions.
Individual Approach
Our consultants are experienced in all aspects of the development life cycle and can guide you the entire way.
Great Experience
We work with each client individually to ensure the project goals are met and the objectives are accomplished.
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.
Our Services
What we do
In the Numbers
20+ years of experience
Ongoing Projects
Finished Cases
+
Satisfied customers
Consultants Worldwide
Projects
Completed Cases
Consumer Products
Sculptura IORT Device
Sculptura IORT Device
Consumer Products
Treatment Planning System
Treatment Planning System on iOS
Consumer Products
TVM Balloon Applicator
TVM Sterile Balloon Applicator
Business solutions
Digital QMS Implementation
Successfully launch and validation an organization's digital Quality Management System (QMS)
Consumer Products
New Medical Device Product Development
Oversaw the Design and Development process for company's new flagship device. Compiled entire Design History File«Sequence Group's regulatory consulting guidance was a tremendous help during the initial growth phase of our organization.»
Larry Johnson
Founder«Sequence Group was vital in providing guidance and support during the design and development process that led the successful deployment of our device to market.»
David S. Thomas
Director of R&D«Sequence Group performed the full software validation on our QMS and helped bridge the gap to bring our company to the next level.»
Melissa Curt
CTOThanks to Sequence Group, we were able to develop our Design History File that helped us launch a successful software project.
Amanda Black
Chief Operating OfficerOur Blog
Latest Posts
Preparing an EU MDR 2017/745 Submission
Preparing an EU MDR Submission The European Union (EU) Medical Device Regulation (MDR) 2017/745 is an important regulation that affects all medical device manufacturers who want to market their products in the EU. Preparing an EU MDR 2017/745 Submission requires a thorough understanding of the requirements outlined in the regulation. This guide will provide an…
February 16, 2023
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The EU MDR 2017/745
Table of Contents The European Union Medical Device Regulation (EU MDR) is a major piece of legislation coming into force in Europe. It represents a major overhaul of the existing regulatory framework for medical devices and will have significant implications for manufacturers, healthcare providers, and consumers. The new regulation is intended to enhance patient safety…
February 16, 2023
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Submitting a 510(k) De Novo to the FDA
Table of Contents A Comprehensive Guide to Submitting an FDA 510k De Novo Navigating the FDA 510k De Novo Process: What You Need to Know How to Prepare Your Organization for the FDA 510k De Novo Process Common Misconceptions About Submitting an FDA 510k De Novo Preparing Documentation for an FDA 510k De Novo...
February 16, 2023
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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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501 East Las Olas Blvd., Fort Lauderdale, Florida 33301