Sequence Group

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.

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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.

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QUALIFIED 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.

20+ years of experience

8+
Ongoing Projects
40+
Finished Cases
25+
Satisfied Customers
5+
Consultants Worldwide
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Completed Cases

TVM Balloon Applicator

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QMS Overview

Management of Generation Changes

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Sculptura IORT Device

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Treatment Planning System

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GentleBeam™

Image-Guided Superficial Radiation Therapy System

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Latest Posts

Quality & Standards
Quality & Standards

IEC 62304: Building a Compliant Medical Device Software Lifecycle

IEC 62304 defines the lifecycle processes for medical device software, scaling rigor to safety Class A, B, or C. Learn t...

Sep 9, 2026Read More →
Quality & Standards
Quality & Standards

Biocompatibility Under ISO 10993: A Risk-Based Approach to Biological Evaluation

ISO 10993-1 is a risk-based biological evaluation process, not a fixed test checklist. Learn how device categorization, ...

Aug 26, 2026Read More →
US Regulatory
US Regulatory

The FDA Q-Submission Program: Getting Early Feedback with a Pre-Sub

The Q-Submission Program lets you get written FDA feedback before you file. Learn what a Pre-Sub is, how to write strong...

Aug 12, 2026Read More →
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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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