EXPERTS SINCE 2011

Operon Strategist is a global consulting firm for the medical device and MedTech industry

We offer product design, manufacturing facility setup, regulatory approvals, and market entry and expansion strategies.

Excellence in Consulting for Medical Device Industry

Operon BuildNext

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

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

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.

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Operon at Glance

Years of Leadership
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Operon Worldwide

Delivering expertise across international markets

New York Office
123 Main Street, NY
London Branch
Baker Street, London
Paris Hub
Champs-Élysées
Dubai Office
Sheikh Zayed Rd
Tokyo Center
Shibuya, Tokyo
Sydney Office
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

13-15 Feb, 2026
Odisha Medical Devices Expo 2026 | Odisha | India
04-05 Jan, 2026
Odisha Medical Devices Expo 2026 | Odisha | India
17-20 Aug, 2025
Odisha Medical Devices Expo 2026 | Odisha | India
09-12 February, 2026
Odisha Medical Devices Expo 2026 | Odisha | India

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

Connect with our development experts

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