ABOUT US

About Operon Strategist: We accelerate sustainable growth for global MedTech innovators and Manufacturers

Operon Strategist is a global medical device consulting partner helping manufacturers achieve regulatory compliance, market access, and sustainable growth in South Africa and international markets. With expertise across regulatory strategy, quality systems, product development, and compliance frameworks, we support medical device companies in navigating complex regulatory requirements with confidence.

From SAHPRA medical device registration and regulatory documentation to ISO 13485 implementation and global certifications, our experts provide end-to-end solutions that help MedTech companies accelerate innovation, reduce compliance risks, and successfully bring safe and effective healthcare products to market.

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Connect with our experts to discuss your next big medical device idea
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Who we are

At Operon, strategy meets execution and global ambitions turn into tangible outcomes

Founded in 2011, Operon Strategist was established with a vision to simplify the regulatory journey for medical device manufacturers and help them build globally competitive healthcare businesses. What began as specialised regulatory advisory has evolved into a comprehensive MedTech consulting partner supporting companies across product development, manufacturing, compliance, and market expansion.

Today, Operon works with medical device manufacturers across 32+ countries, delivering strategic consulting solutions that combine regulatory expertise, technical knowledge, and practical execution. Our South Africa-focused services help organisations navigate SAHPRA requirements, establish compliant quality systems, and achieve successful market entry.

We believe excellence is not just a service standard—it is the foundation of every partnership we build.

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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

PSS Urology

The medical device manufacturer

Australian Orthopaedic

The orthopedic manufacturer

Incredible 3D Implant

Manufacturer of medical device
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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.
To deliver world-class, technology-enabled consulting solutions that are accessible, reliable, and cost-effective and to build long-term partnerships based on trust, quality, and on-time delivery.
We believe that every life-improving device deserves a clear, compliant, and efficient path to the market. Our work ensures that manufacturers move forward with certainty, never guesswork.

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

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Mrs. Lakshmi Ranjithkumar

Regulatory Affairs

Dr. Anil Kumane

Project Head

Mr. Sandip Somvanshi

Business Development

Creating Meaningful Impact

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

Mitigates Risk

Identifies gaps early and prevents costly compliance failures.

Ensures Accuracy

Brings precision to documentation, data, and regulatory submissions.

Saves Time & Money

Streamlines processes so you avoid delays, rework, and audits.

Enhances Visibility & Accountability

Creates clear oversight, reporting, and traceability across teams.

Leverages Licensing

Unlocks certifications and approvals that expand your market potential.

Accelerates Market Entry

Builds the fastest, cleanest pathway from idea to commercialisation.

Cross-border Experience

Strong network and capability to guide global expansion smoothly.

360° MedTech Expertise

Integrated solutions covering design, setup, compliance, and scale-up.

Operational Excellence

Refined workflows, frameworks and planners that strengthen efficiency, quality, and project performance.

World-class Service

Dependable support from concept to post-launch growth.

One Point of Contact

A single, dedicated strategist managing every moving piece.

Transparent pricing & Confidentiality

Clear cost structures with no hidden surprises. Ensuring confidentiality of the project.

Define

Align requirements, strategy, and regulatory pathways.

Develop

Build robust designs, documentation, and compliant facilities.

Deploy

Secure certifications, pass audits, and launch confidently.

Medical Device Manufacturers

MdTech Innovators

Drug-Device Combination Devices

Primary Packing Materials

Our Prestigious Clients

Built on outcomes, accountability, and long-term trust

Ready to Build Your Medical Device the Right Way

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Mr. Anil Chaudhari

Founder & CEO

With over 25 years of experience in regulatory affairs and quality assurance, Anil Chaudhari brings deep expertise across the medical device and medtech industries. Under his leadership, Operon Strategist has grown into a trusted global consulting partner, enabling organizations to build robust quality systems, achieve international certifications, and scale compliantly across global markets.

Holding an M.Sc. in Microbiology, he combines strong technical foundations with strategic insight to help organizations navigate complex global regulatory environments. Trained alongside regulatory authorities in the United States and Europe, Anil advises both domestic and multinational medical device companies on compliance, quality systems, and market readiness.

As part of the CITD program, a European Commission–Government of India initiative, Anil has played a key role in strengthening awareness of European medical device regulations in India. His leadership and commitment to excellence position Operon Strategist as a trusted partner for global medtech growth.