PHAROS.
Regulatory Group

Bringing devices to market.
Faster.

Regulatory and clinical affairs for medtech startups. We handle the expertise so you can focus on the device.

Contact
0+
Years of clinical practice
0
Regulatory jurisdictions covered
0
Notified Bodies with accepted documentation
0
Working languages
Why Pharos exists

Startups need regulatory and clinical expertise. Most can't afford to hire it.

Pharos began inside the industry. After two decades of medical practice, I spent years working with medical device manufacturers: their processes, their audits, their Notified Body submissions.

From that position, one gap was impossible to miss. Startups carry the same regulatory obligations as the largest manufacturers, with none of their resources. They cannot afford an in-house regulatory and clinical affairs department, and the large CROs are not set up to take them on.

I founded Pharos to close that gap: senior regulatory and clinical work, sized and priced for medtech startups, with the same rigor large manufacturers get.

Why startups choose Pharos

  • ✓Works as your regulatory and clinical affairs department, on contract
  • ✓Physician-led: 20+ years of clinical practice behind every clinical evaluation
  • ✓Documentation accepted by Notified Bodies, Class I through Class III
  • ✓On the ground in Latin America's medtech manufacturing hub
  • ✓Fixed milestone pricing, agreed before work begins
Our solutions

What we do

From study protocol to post-market surveillance.

Documentation reviewed and accepted by leading Notified Bodies

EU MDR UKCA FDA Health Canada ANVISA TGA
Karen Elizondo
Who we are

The physician behind Pharos

Karen Elizondo, MD — Founder

For over two decades, I practiced medicine, with a special focus on women's health. That experience shaped the way I approach my work today in the medical device industry, where I partner with manufacturers to bring safe, effective technologies to market. I handle clinical evaluation, medical writing, and the technical documentation required for Class I, II, and III devices.

Notified Bodies have reviewed and accepted my submissions. My regulatory experience covers EU MDR, UKCA, FDA, Health Canada, ANVISA, and TGA, and I collaborate with clients in English, Spanish, and Portuguese.

Clinical practice
20+ years, focused on women's health
Device classes
Class I · IIa · IIb · III
Jurisdictions
EU MDR · UKCA · FDA · Health Canada · ANVISA · TGA
Working languages
English · Spanish · Portuguese

A clinical evaluation answers a medical question: does the evidence show the device is safe and performs as intended? I write them as a physician first, starting from the evidence.

Work with Pharos
Contact

Request a proposal

Whether you are preparing your first EU MDR submission, fixing a clinical evaluation after Notified Body findings, or planning entry into a new market, write to us.

Initial consultations are confidential and without obligation. I respond within 24 hours.