Solution:

Regulatory & Quality

 

 

The regulatory space can seem confusing and complex. That’s where we come in. Our friendly team helps to demystify the complexities of regulatory pathways and quality systems. Working together, you’ll be guided by a concrete strategy backed by confident execution of deliverables.

Regulatory & Quality Services

Example services that our regulatory and quality experts can
assist you with include:

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  • Regulatory landscape and strategy
  • Internal audits
  • Clinical evaluation reports (CERs)
  • Q-submissions and FDA interaction
  • Clinical study IDE, IND applications
  • 510(k), De Novo, PMA, BLA
  • Breakthrough or RMAT designation
  • Quality systems, SOPs, MDSAP
  • MDR Gap analysis and strategy
  • PMS and PMCF procedures
  • CE Mark
  • Technical files

Telos strives to be more than just “regulatory and quality specialists.” We put ourselves in your shoes to ensure our services are in lockstep with your goals as if Telos is an extension of your business and a part of your team.

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.

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Define Your Goals

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

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Identify Services & Plan

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

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Deliver Solutions

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

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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.

Start the Conversation

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

Connect to get Started