Anil Chaudhari

Anil Chaudhari is the Founder and CEO of Operon Strategist, a medical device consultancy firm based in Pune, Maharashtra, India.1 He is an experienced medical device regulatory consultant with expertise in various areas of the medical device industry.1

Professional Background

Anil Chaudhari founded Operon Strategist in February 2012 and has been leading the company since then.1 His areas of expertise include:

• Medical device regulatory consulting
• USFDA consultancy
• ISO 13485 consultancy
• 510(k) consultancy
• Turnkey project consultancy for medical device manufacturing

Company Overview

Operon Strategist, under Anil Chaudhari's leadership, provides a range of services to the medical device industry, including:

• Regulatory compliance and approvals (e.g., CDSCO, Indian FDA, CE MDR, 510(k), MDSAP, SFDA, UKCA)
• Quality management system implementation (e.g., ISO 13485, ISO 15378)
• Medical device factory setup
• Product development assistance
• Technical dossier compliance and review

The company has successfully handled over 60 projects related to the medical device manufacturing industry, with 30+ being turnkey projects involving layout design, clean room design, facility plant setup, and process validation.1

Achievements and Recognition

Anil Chaudhari has been recognized for his contributions to the healthcare and medtech industry. In 2023, he was named one of the top 50 Healthcare and Medtech Leaders by Medgate.3

Contact Information

For those seeking to connect with Anil Chaudhari or Operon Strategist:

• Email: anil@operonstrategist.com or anilmchaudhari@gmail.com
• Mobile: +919823283428
• Office Address: 13, "A" Tower, Third Floor, Sagar Complex, Kasarwadi, Pune: 411 0342

Anil Chaudhari's LinkedIn profile can be found under the username anil-chaudhari-44637412, as mentioned in the query.