WHO WE ARE

REGHELPS is a global medical device regulatory consultancy firm that also serves as a European Authorized Representative.

INFORMATION

WHAT WE DO

We’re not just average consultants; we combine unrivalled knowledge with cutting-edge service capabilities to assist

INTEGRATION

WHERE WE WORK

Medical device manufacturers in overcoming regulatory issues by navigating the regulatory landscape for early certification.

IMPLEMENTATION

A GLOBAL VIEW

Our team of experts and consultants from different countries and regions support for the implementation

EXPERT CONSULTANTS

Find a consultant in our team with specific knowledge of your device is easy.  We have a large team.

CLIENT FOCUS

Focus on early certification and low number of review comments from authorities

ECONOMIC PRICING

Fixed fees structure and flexible payment schedules make us different from others.

QUESTIONS ABOUT REGULATORY COMPLIANCE ISSUE?

Ask An Expert

“For the past 21 years, we’ve been serving customers all around the world. What I have cherished most about our relationship with our business clients in the medical device space as we have developed and evolved.”

Peter Rawlinson • Senior Associate

EUROPEAN UNION

CE Marking under EU 2017/745 and EU 2017/746 complete service under one roof covering,

UNITED KINGDOM

UKCA Marking under UK MDR 2002 and MHRA registration service under one roof,

UNITED STATES

FDA Compliance covering FDA Registration & listing along with 510k service under one roof,

LET’S WORK TOGETHER

We work as a single united team with market leading firms around the world and give our clients the highest quality advice possible.

MAKE ENQUIRY