Regulatory Affairs

The regulatory space
is complex. We’ll help
navigate it.

Kaleidoscope Innovation’s Regulatory Affairs team helps medical device entrepreneurs, designers, and manufacturers bring their products from concept to market.

We are passionate about demystifying the regulatory process, doing our part to ensure great ideas reach the world faster to improve the lives of more people.

Let’s Talk

Your success depends
on effective, efficient support.

Personalized Attention + Services
Whether you’re a large corporate entity, a small startup, or an academic institution, Kaleidoscope Regulatory Affairs provides all our clients with engaged, personalized attention and services.

  • Planning and strategy for licensing
    and marketing
  • Quality assurance support and
    program implementation
  • Regulatory submissions including IDE, BDD, HDE, 510(k), De Novo, PMA, EU MDR, and
    Q-Submission meetings
  • Post-market surveillance and remediation support for 483s and Warning Letters

Case Study

Learn how Kaleidoscope’s Regulatory Affairs and Human Factors departments collaborated to help our client obtain FDA clearance for a new cardiac catheter.

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With the wide variety of regulated products our team develops, having an experienced and multi-faceted regulatory partner to work alongside us is critical. The team at Kaleidoscope goes beyond providing regulatory guidance – they walk with us as we concept, develop, and validate our products.

Michael Schmidt
Assistant Vice President, Orlando Health

Our expertise goes
beyond regulatory affairs.

Product Development Resources and Support
As part of Kaleidoscope Innovation, a world-leading design, product development, and consulting firm, we can offer clients more than just regulatory support, including end-to-end product development research and expertise as well as access to resources in emerging tech through our parent company, Infosys.

What’s more, our frequent close collaboration with Kaleidoscope’s multi-disciplinary departments—including engineering, human factors, and prototyping shop—gives us an immersive understanding of every phase of the product development process. It’s an invaluable level of insight and experience we bring to every project.

Get to Know Kaleidoscope Innovation

Collaborative Teams

We frequently collaborate closely
with these Kaleidoscope teams.

  • Human Factors
  • Engineering
  • Machine + Electronics Shops
  • Clinical Sciences
  • Project Managment
  • Quality Affairs

Schedule a consultation.

We welcome the chance to help get your product or device to market safely and efficiently.
Get in touch.

Colleen Murphy
Director of Regulatory Affairs |

Colleen is a seasoned regulatory and clinical professional with over 25 years of experience in medical devices, in vitro diagnostics, and pharmaceuticals. Today, she leads our Regulatory Affairs team.

LP Contact - Colleen
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