How Can We Help?

“I need a to get a 510(k).”

How Can We Help?

“We need to convert from Human Cells, Tissues, and Cellular & Tissue-Based Product (HCT/P) designation to a Biologics License Application (BLA).”

How Can We Help?

“I need help with my internal audits.”

How Can We Help?

“I need help in designing a clinical study.”

How Can We Help?

“We need post-market clinical follow-up data.”

How Can We Help?

“We need to set up a registry.”

How Can We Help?

“We need to do a systematic literature review.”

How Can We Help?

“We need to publish these results in a peer-reviewed journal.”

How Can We Help?

“We need a health economics analysis.”

Your Objective,

Your Success

Your Objective, Your Success

Contact Us

We specialize in partnering with medical device and biotechnology companies through a tailored approach that helps these companies understand and achieve their ultimate business goals in regulatory, quality, and reimbursement strategies.

What Are Your Objectives?

We are more than just consultants, medical writers, or regulatory specialists working on a project for you. Instead, we partner with you to ensure our services are customized to your needs.  Think of us as an extension of your team, helping you every step of the way to achieve your own telos– or ultimate goal.

Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device

Regulatory & Quality Solutions

We demystify the complexities of regulatory pathways and quality systems to provide a concrete path-forward.

Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device

Clinical Adoption

Utilizing a full range of scientific tools, we create and communicate evidence to demonstrate your product’s value proposition.

Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device

Reimbursement Strategies

Our strategic approach provides clear steps to reimbursement by defining the medical needs, clinical benefits, and economic insights for payers.

Trusting in Telos is Telos trusting in your business – because when we help your business advance, we help improve the quality of patient care.

Telos by the Numbers

62

FDA Clearance or Approvals

+300

Meetings with Regulatory Bodies

+100

Scientific Protocols Developed

70

Clinical Studies Run

90

Pre-Clinical Studies Run

Years of Regulatory & Quality Experience

Years of Cumulative Experience Collaborating with Clinicians/KOLs on Pre-Clinical and Clinical Science

Our Services Capabilities Integrate to Provide the Best Possible Solution and Service Combination for our Clients.

Telos services are integrated

“Telos pulled us out of the fire a bunch of times. There were times that I called Telos and said that I need this and this by this date… and they would always deliver. Telos’ flexibility and their ability to hit deadlines to turn things around quickly was a game changer.”

Four Steps to the
“Ultimate Objective”

As your partner, Telos invests time and effort from the onset of connection to understand your ultimate business objectives. This approach helps us to prescribe and provide the right services for success. Telos means “ultimate objective” – let us help you reach yours.

Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device

Define Your Goals

Telos works with you to clearly understand your business’ goals. We ask “Why” instead of “How.”

Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device

Identify Services & Plan

Our team identifies service areas where we can partner to create a plan unique to your business.

Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device

Deliver Solutions

We’ll work with you through each phase to accomplish the milestones identified in the plan.

Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device

Repeat as Business Scales

Because we see each client as a true partner, we remain ready to help your business scale as new needs arise.

How We Meet Your Objectives

Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device

EVIDENCE SERVICES

Your products’ success starts with the foundations of pre-clinical, clinical, and health economics evidence.

We leverage a wide range of analytical approaches and forums of communication to convert your data to disseminated evidence.

Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device

REGULATORY & QUALITY SOLUTIONS 

Whether seeking novel indications or aiming for first-time marketing approval, our expert regulatory and quality teams will help you win in a competitive landscape.

Our experts provide your team access to over 40 years of regulatory and quality subject matter expertise globally and ensure you have round-the-clock compliance to stay ahead.

Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device
Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device
Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device

Why An Integrated Approach?

Our evidence, regulatory, and quality services operate in a unique, integrated fashion to achieve your ultimate goals by circling-up around each objective.

Instead of providing services, we work to provide intrinsic value to your success. View our case studies to see how we’ve helped clients just like you:

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Our Clients and Partners

Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device
Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device
Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device
Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device
Regulatory and quality solutions,Reimbursement strategies,clinical adoption,Telos partners,medical device

We look forward to learning about your project and sharing ideas.

Connect to get Started