EXPERTS SINCE 2011
Operon Strategist is a global consulting firm for the medical device and MedTech industry
Excellence in Consulting for Medical Device Industry
OPERON
BUILDNEXT
Integrated consulting for medical device & facility setup
From concept to operational readiness, we design, plan, and execute compliant, world-class medical device facilities.
OPERON
ElevatePlus
Global regulatory & compliance expertise
Enabling medical devices to meet international standards through end-to-end expertise across global approvals, certifications, and compliance.
OPERON
MarketEdge
Enabling medical devices to scale globally, strategically
Enabling medical device companies to scale globally through data-driven go-to-market strategies, sales alignment, and sustainable market expansion.
Our Story
At Operon, strategy meets execution and global ambitions turn into tangible outcomes
Founded in 2011, Operon was established with a clear vision: to make medical device businesses smarter, compliant, and globally competitive. What began as specialized regulatory advisory has evolved into a full-service strategic partner for medical device and technology companies worldwide.
Today, Operon operates in 32+ countries, enabling medical device organizations to scale with confidence through integrated expertise in execution, compliance, and growth. Excellence is not just what we deliver — it is the standard that defines who we are.
Operon at Glance
Operon Worldwide
Delivering expertise across international markets
123 Main Street, NY
Baker Street, London
Champs-Élysées
Sheikh Zayed Rd
Shibuya, Tokyo
George Street
Who We Serve
Trusted by startups, SMEs, global MedTech leaders
Medical Device Manufacturers
MdTech
Innovators

Drug-Device Combination Devices
Primary Packing Materials
Our Clients
Trusted by startups, SMEs, global MedTech leaders
Medical Device Regulatory Consulting Services

CE Marking | CDSCO

SFDA

Oman Registration | EDA | SAHPRA

CE Marking | CDSCO

SFDA

Oman Registration | EDA | SAHPRA
Upcoming Events & Exhibitions
How we work at Operon
An integrated approach designed to take medical devices from concept to global markets

Define
Align requirements, strategy, and regulatory pathways

Develop
Build robust designs, documentation, and compliant facilities

Deploy
Secure certifications, pass audits, and launch confidently
Ready to Build Your Medical Device the Right Way
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