Building a Quality Foundation for Global Market Access

Client Overview

Thrive Orthopedics is a U.S.-based orthotic device company focused on mobility and musculoskeletal support. Founded in 2021, they make a portfolio of Class I devices: ankle foot orthothosis ankle braces, carbon fiber insoles, and the Equinus Brace, for patients and clinicians looking for modern, functional options.

The company started with a small team and their attention was where it needed to be: getting products in front of customers and building traction. When international distribution conversations started to pick up, the question became whether their quality foundation could support what was coming next.

The Challenge

Thrive Orthopedics launched in mid-2021 without a formal Quality Management System. The team was covering their operational bases, but informally, without documentation that would hold up to regulatory review. For a small Class I device company focused on market traction, that was a workable starting point. After a year, they realized they needed more support.

That is when a real EU distribution opportunity surfaced. Getting products into the European market meant CE marking under EU MDR, subsequently leading to technical files, design and development documentation, a compliant QMS, and a registered authorized representative in the EU. At that point, none of that existed and no one on the team had the regulatory background to build it.

Three things made the situation especially difficult:

• No QMS and no documentation to build from
• No internal EU MDR experience
• A small founding team already spread across sales, product, and operations

They needed someone who could own the quality and regulatory work and move fast, without adding drag to everything else the business was trying to do.

Why Rook Quality Systems

Thrive Orthopedics connected with Rook Quality Systems through a referral from a contact at Greenlight Guru. After an initial conversation, they had a clear direction: Rook would put a dedicated quality manager on the account and work directly inside the business, rather than alongside it from afar.

This had significant value for a small team because getting passed between consultants every few months, or working with someone who doesn't know your products, costs a significant amount of time. The Rook model meant one consistent person who would dedicate their time to get to know Thrive Orthopedics and stay with them throughout the process.

Rook’s Approach

Since there was no existing QMS to inherit, Rook started from scratch with a product portfolio, a small team, and a business that needed to reach the EU market quickly.

The Rook quality manager assigned to Thrive Orthopedics built the QMS and technical documentation in parallel rather than in sequence, so the regulatory work moved alongside the business rather than waiting for it.

Over the course of the engagement, Rook:

• Built a complete QMS from scratch, aligned with ISO 13485:2016 and EU MDR and sized for a small, growing company
• Developed Design and Development Files for the full device portfolio, covering the technical documentation needed for EU MDR compliance and CE marking
• Identified and helped qualify a local EU authorized representative with direct experience in orthotics and prosthetics, who independently reviewed the technical files before submission
• Managed ongoing QMS operations including internal audits, document control, and management review on a regular cadence as the company scaled
• Supported new market and distribution conversations as they came up, keeping the quality system current with new requirements
• Assisted with vendor and supplier qualification as the supply chain developed

The relationship started with weekly calls and eventually evolved into a bi-weekly rhythm as operations stabilized. The same quality manager stayed on the account the entire time, which meant Rook was not re-learning the business every time something new came up.

The Results

Thrive Orthopedics had products on the EU market within approximately one year of starting the regulatory workstream. This meant they had a QMS built from scratch, technical files written, authorized representative qualified, and CE marking in hand. That timeline held because the quality work ran alongside ongoing business operations.

 A few additional noteworthy outcomes: 

• Full ISO 13485:2016-aligned QMS built from the ground up in the first year
• Technical documentation that Thrive Orthopedics' EU authorized representative described as among the strongest files he had seen in the orthotics and prosthetics space
• A quality system that held up when distribution partners wanted to review it, with Rook brought directly into those conversations
• Ongoing compliance maintained without a full-time internal quality hire

Getting the quality foundation right early did not slow Thrive Orthopedics down. Instead, it got them into Europe and it continues opening new doors as the business grows.

Ongoing Partnership

Rook Quality Systems continues to work with Thrive Orthopedics as an embedded quality partner. The scope has grown with the business: new international markets, distribution partner reviews, annual internal audits, and day-to-day document control, all through the same relationship that started in 2022.

The quality manager knows the products, the history, and how the company operates. That is not something you rebuild easily, and for a company at Thrive Orthopedics' stage, it is what makes the difference between a quality function that slows you down and one that keeps you ahead of competitors.