Operon Strategist

At Operon, strategy meets execution and global ambitions turn into tangible outcomes
Founded in 2011, Operon Strategist is a medical device regulatory consulting firm that helps manufacturers build the systems, discipline, and compliance strength needed to compete globally. We specialise in creating clarity, structure, and regulatory confidence for organisations navigating a complex and fast-evolving medical device landscape.

Our expertise spans QMS implementation, audit readiness, certification support, and compliance frameworks that strengthen quality and reduce operational risk. We also streamline internal processes, modernise documentation, and enable teams to adopt efficient, technology-backed workflows.

With clients across 32+ countries, we work directly with leadership teams, quality heads, and technical professionals to align people, processes, and systems with international expectations. Our approach is practical, structured, and focused on long-term capability building. Wherever you want to go, we help you get there – compliantly, confidently, and strategically.

Years of
Leadership
15
+
Markets
Navigated
32
+
Trusted
Partnerships
950
+
Services
Delivered
3500
+
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 clients to secure regulatory approvals and global market access through end-to-end expertise in certifications and compliance for their devices.

Operon MarketEdge
OPERON
MARKETEDGE
Enabling medical devices to scale globally, strategically

Enabling medical device companies to scale globally through market intelligence services, market authorisation and sustainable market expansion.

Testimonials
Hear what our customers are saying

Incredible 3D Implant
Manufacturer of medical device

PSS Urology
The medical device manufacturer

Australian Orthopaedic
The orthopedic manufacturer
Know More
To be a leader in MedTech regulatory consulting and turnkey project execution, setting new benchmarks of excellence, integrity, and innovation in the medical device industry.

Our People & Leadership
We are defined by our people and are deeply committed to creating a diverse and inclusive culture.

Mr. Anil Chaudhari
Founder & CEO

Read More

Mrs. Lakshmi Ranjithkumar
Regulatory Affairs

Dr. Anil Kumane
Project Head

Mr. Sandip Somvanshi
Business Development

Creating Meaningful Impact
We are committed to enable safer, compliant medical innovation while acting as responsible partners to our people, our clients, and the communities we serve

Why do you need a medical strategist as your ally
Why choose Operon Strategist as your consultant
How do we work
Who we serve

Our Prestigious Clients
Built on outcomes, accountability, and long-term trust

Sidapharm
Frido
Alkem_Medtech
ShahEyeCare
MST_Microsurgical
arkray
brisk
Galaxi-Sugicals
helyxon
kalyani group
Ready to Build Your Medical Device the Right Way
Connect with our development experts

I allow Operon Strategist and its representative to contact me about its offerings and services.
To Get Latest Updates And News On Operon Read And Subscribe To Our Newsletter
Email