720.215.9244 info@novaremedical.com
A Principal-Led Practice for Medical Devices
For Medical Device Innovators
Quality · Regulatory · Development · Sustaining
A Principal-Led Practice Since 2021
For Medical Device Innovators

Transforming today's challenges into tomorrow's success.

Novare partners with device innovators across quality, regulatory, development, and sustaining disciplines — bringing the experience to design what's next, build it well, stand it up to scrutiny, and maintain compliance. Our Principals have led these programs from inside the industry, and we work alongside your team to move forward together.

Schedule a Consultation → Our Core Pillars →
Trusted by Medical Device Innovators
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Why Novare

We take a global approach to your local challenges.

What defines our team is a genuinely global perspective. Our Principals have vast experience leading teams across Europe, Asia, and the United States — working inside different regulatory frameworks, competing in different markets, and navigating the unwritten rules that shape how business actually gets done. That global footprint taught us something essential: the best solution for your challenge isn't a one-size-fits-all playbook. It's an approach that accounts for where you operate, who your customers are, and the cultural realities on the ground.

We bring that cultural intelligence to everything we do. It's how we think. It's why we believe in taking a global approach to your local challenges.

More About Novare →
Core Pillars

Four core pillars. One integrated team.

Each pillar is led by a Principal with direct industry experience and supported by senior subject matter experts. We work across all four — and most engagements draw on more than one.

i.

Quality Management

Build a Quality Management System that scales with your organization — one that satisfies FDA QSR/QMSR, EU MDR, and ISO 13485:2016, while staying practical enough for your team to operate every day.

QMS Design CAPA Programs Internal Audits Supplier Quality Management Review
Explore Quality →
ii.

Product Development

Design and develop your next product — from concept through verification, validation, and design transfer. We bring decades of experience building Design History Files (Design and Development Files) that satisfy FDA, EU MDR, and ISO 13485 from day one.

Design Controls Design History Files V&V Planning & Execution Risk Management (ISO 14971) Design Transfer
Explore Development →
iii.

Regulatory Compliance

Chart your path to market and maintain it once you're there. We support FDA, EU MDR, and international submissions — and partner with you through inspection readiness, audits, and post-market obligations.

510(k) / De Novo / PMA EU MDR Technical Files Inspection Readiness International Registration Post-Market Surveillance
Explore Regulatory →
iv.

Sustaining & Operations

Keep your device on the market and your operations running. We support sustaining engineering, process optimization, supplier transitions, and the everyday work of keeping a commercialized device healthy across its lifecycle.

Sustaining Engineering Process Validation Manufacturing Transfer Supplier Transitions Lifecycle Support
Explore Sustaining →
Who We Serve

What applies to you depends on who you are.

QMS scope, regulatory burden, and compliance obligations vary significantly by entity type. We help every category of medical device company — from manufacturers carrying full QMS responsibility to distributors with focused obligations.

US Manufacturer

Full QMS scope under 21 CFR 820 / QMSR — design controls, production, and post-market.

Foreign Manufacturer

Full QMS plus US-specific obligations: Establishment Registration, US Agent, GUDID.

Importer · Distributor

US and EU distribution roles with targeted QMS scope and reportable event obligations.

Repackager · Relabeler

QMS scope focused on labeling, packaging, traceability, and post-market reporting.

A Diagnostic Tool

What QMS elements apply to your entity type?

Our QMS Applicability Matrix maps every regulatory requirement against six entity types — so you can see at a glance what's in scope for your organization and what isn't.

Mfr
Distr
Repack
Quality Manual
Y
Y
Y
Design Control
Y
—
—
Risk Management
Y
Y
Y
Process Validation
Y
—
Y
Software Validation
As Appl.
—
As Appl.
+ 22 more requirements →
Explore the Full Matrix →
Our Team

Led by industry Principals.

Novare's Principals don't just oversee engagements — they lead them. Each brings decades of medical device experience as engineers, quality leaders, regulatory directors, and executives. When your team works with us, you work with people who have done the job.

Jared Headshot
Jared
Founder & Principal

Jared founded Novare in 2021 after a career inside medical device manufacturers leading quality systems, regulatory programs, and product development. His engagements span QMS design, FDA submissions, and Design History File (Design and Development File) development for both startup and established device companies.

Joining as Principal
Mike Headshot
Mike
Principal

Mike brings decades of industry leadership across regulatory affairs, clinical operations, quality management, and program execution at established medical device organizations — including hands-on experience as a manager, teacher, and executive in regulated industry.

Meet the Full Team →
Client Voices

The right partner makes the complex possible.

From first submissions to FDA inspection responses, from concept to design transfer, our clients trust us with work that has to be right.

Novare Medical is staffed with subject matter experts that have worked in the medical device industry at successful organizations, come with contemporary knowledge, that allowed them to truly consult our organization on challenging topics such as implementation of European Medical Device Regulations, Design History File remediation and the submission of regulatory applications to domestic and foreign regulatory authorities. Novare’s staff proved exceptional in their ability to meet our timelines when executing on the aforementioned project and they came in right on budget.
Orthofix
It has been a pleasure to work with Novare. As a small company, we are looking for a partner that understood the unique challenges associated with our business model as we grow and face technical, regulatory, and strategic business obstacles. Novare was a great fit for us and helped us to achieve fast effective results in all of these areas. I highly recommend Novare to anyone looking for a one-stop-shop that can support product development, quality management systems, compliance, and manufacturing.
Pacific Instruments
Novare brings a wealth of knowledge and expertise to the table. Not only are they well-versed in every facet of medical device design and development, but they are a joy to work with and seamlessly integrated into our company’s culture and project management style.
SeaSpine
Now part of Orthofix
The sage counsel and experience of Novare Medical Consulting was both instructive and empowering. I appreciate the care and focus they applied to our business and quality program.
Allison Medical
Partnering with Novare made navigating the complex world of FDA medical device markets incredibly straightforward and stress-free. Their team was not only thoroughly detailed and precise in their work, but also wonderfully relatable and easy to collaborate with throughout the entire process.
Edge Biologicals
Insights

Guidance for navigating regulated industry.

All Resources →
Brochure

Novare Capabilities Overview

Our complete service offering, principal credentials, and engagement models in a single shareable PDF. Read this if you're evaluating consulting partners, building a budget for an upcoming program, or need to introduce Novare to your leadership team.

Download PDF → White Paper

The Quality Manual as the Foundation of Your QMS

Your Quality Manual sets the architecture for everything that follows it. Read this if you're standing up a new QMS, your existing manual was written years ago, or you've found yourself unable to explain how your system actually works.

Download PDF → White Paper

The Strategic Value of Management Review

Management Review is often treated as a checkbox — but done right, it's the leadership-level lever that drives QMS effectiveness. Read this if your management reviews feel performative or your CAPA program isn't producing systemic improvement.

Download PDF →

Let's talk about what's next.

Schedule a no-cost consultation. Whether you're developing a new device, building your quality system, mapping a regulatory pathway, or sustaining what you've already launched — we'd love to hear what you're working on and how we can help you.

Schedule a Consultation →