Team

Three regions, one team.

Reglo Medical Consulting LLC is a California-registered regulatory consulting company for medical device and IVD manufacturers, with representatives in the US, France and China working as one team.

EX

California, US

Emily Xiong

Leads US services

Emily Xiong leads Reglo’s US services. She brings eight years of regulatory affairs experience at large multinational medical device companies, working on Class II and Class III devices in vascular and diabetes care, including PMA support, and led an EU MDD-to-MDR transition through to a successful global launch. She manages FDA submissions, US Agent service and client projects end to end. A certified ISO 13485 internal auditor, she has extensive experience with internal and external audits.

  • FDA submissions
  • US Agent
  • PMA support
  • MDD → MDR
  • ISO 13485 auditor
LA

Paris, France

Lya Ao

Leads European work

Lya Ao leads Reglo’s European work. A biomedical engineer trained in France, she has managed regulatory projects since 2021, covering FDA 510(k), EU MDR, China NMPA and other international submissions for medical devices and software. Her experience spans EU MDR technical documentation, quality management systems (QMS), risk management and clinical investigation. A certified ISO 13485 internal auditor, she works directly with notified bodies, prepares manufacturers for audits and advises on EU reimbursement.

  • EU MDR
  • Notified bodies
  • QMS
  • Clinical investigation
  • EU reimbursement
LZ

Shenzhen, China

Lisa Zhang

Leads work with manufacturers in China

Lisa Zhang leads Reglo’s work with manufacturers in China. She brings more than four years of global regulatory experience in consulting and in-house leadership roles. She has led more than 15 registration projects under FDA 510(k), EU MDR and China NMPA for active devices, software and IVD, and secured registrations in more than 20 countries and regions, including 11 for a single laser device. She has supported four FDA, EU MDR and MDSAP audits, each passed on the first attempt.

  • FDA 510(k)
  • China NMPA
  • 20+ countries
  • MDSAP
  • Active devices & IVD

When your day ends, ours is still going.

California

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Pacific Time

Paris

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Central European Time

Shenzhen

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China Standard Time

Every project has a lead and a second contact, chosen by where you are, and associate consultants support each representative. We work in English, Chinese and French.

Which markets are next for you?

Tell us about your device and where you want to sell it. We will give you an honest view of the pathway and a first step.

Book a 30-minute callEmail info@medreglo.com