ABOUT US

Global Medical Device Regulatory Consulting & Compliance Partner

Our clients are shaping the future of healthcare. They innovate, validate, and scale—navigating highly complex European and international regulatory and operational landscapes. As a trusted partner in medical technology consulting, we collaborate with MedTech leaders from concept to commercialization, seamlessly aligning strategy, compliance, and execution across global markets. From navigating strict EU MDR consulting pathways to achieving worldwide market readiness, we enable confidence at every step. We ensure your medical device innovation reaches global healthcare markets—faster, safer, and sustainably.

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Who we are

At Operon, strategy meets execution, transforming global ambitions into tangible regulatory outcomes

Founded in 2011, Operon Strategist is a premier medical device regulatory consulting firm that helps manufacturers build the robust systems, operational discipline, and compliance strength needed to compete globally. We specialize in providing expert regulatory guidance, creating absolute clarity, structure, and confidence for organizations navigating a complex, fast-evolving global compliance environment.

Our comprehensive medical device consulting expertise spans ISO 13485 QMS implementation, MDSAP audit readiness, CE marking certification support, and robust risk management frameworks that strengthen quality while significantly reducing operational risk. We also streamline internal technical files, support specialized IVD regulatory consulting requirements, and enable manufacturing teams to adopt highly efficient, technology-backed validation workflows.

With an established global footprint across 32+ countries, we work directly with corporate leadership teams, quality heads, and technical professionals to align people, processes, and systems with stringent international expectations—including US FDA 510(k) clearances. Our approach to medical device regulatory affairs consulting is practical, structured, and focused on long-term internal capability building. Wherever you want to take your company, we help you get there—compliantly, confidently, and strategically.

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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 are 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.