Contact No:+91-9823283428, +020-65283428
Email-id : info@operonstrategist.com ,anilmchaudhari@gmail.com

Global Medical Device Regulatory Consultant

1.Medical Device And IVD Registration. 2.Local representation for medical device and IVD companies. 3.Regulatory Consulting.

Read more
Medical Device Regulatory Consultant

Register your Medical Device into 125+ Countries.

TGA Registration , ANVISA Registration , US FDA Registration , Medical Device Registration Russia.

Read more
Register your Medical Device into 125+ Countries

Medical device and IVD Registration Into European union

Medical Device Registration Into Australia , France , Belguria , Italy , ireland , Denmark , United Kingdom , Germany.

Read more
Medical device and IVD Registration

Medical Device Regulatory Consultant

We provide Regulatory Consulting Services For Iso 13485 , US FDA Registration , CE Marking , CDSCO , FDA , 21 Cfr part 820.

Read more
Medical Device Regulatory Consultant

Medical device and IVD Registration into Central & East Asia , South America

Medical device and IVD Registration into Central & East Asia , South America.

Read more
Medical device and IVD Registration

Primary Packaging Regulatory Consultant

We provide Regulatory Consulting Services For Iso 15378 , 21 cfr part 210 & 211 , dmf File submission .

Read more
Primary Packaging Regulatory Consultant

US Fda Registration Consulting Services

US Fda Registration , US FDA Regulatory Consulting Services For Medical Device Manufacturing Industry.

Read more
US Fda Registration Consulting

Register Your Medical Devices into
100+ Countires

Our global presence & satisfied client base across the globe US Algeria France Brazil Australia Qatar India Malaysia

Read more
image01

About operon

Operon strategist is the pioneer technical consultancy & Regulatory advisory company providing technical guidance to the manufacturer, distributor in medical device industries and assist them to improve their business at national and international levels. Company provides the wide range of technical guidance to Medical device, Cosmetics, Ayurveda and Health care industries who are looking to enter in global market. Our ultimate goal is to helps them to obtain in-country regulatory approval and export their products to destination market.


We assist medical device companies for Device registration, quality management system compliance, Audit compliance, Development of products at each phases, Technical dossier compliance and review.

We are dedicated to providing guidance for regulatory compliance through our expertise technical team whose knowledge, experience and ability towards solving critical challenges related to quality make them sure to handle clients both national and international levels and compliance to quality management system. Our team evaluates manufacturing operations, identifies areas for improvement and executes system compliance.

Operon Strategist is a technical consultancy regulatory advisory company providing consultancy guidance to various manufacturers in the healthcare industry to ensure strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications. We provide complete turnkey solution to manufacturers looking to set up a world-class manufacturing unit. We also provide customized packages as per the requirements of the client.

Register your Medical Device Into 100+ Countries

Costa Rica

Medical Device Registration into Costa Rica

Algeria

Medical Device Registration into Algeria

Brazil

Medical Device Registration into Brazil

Medical Device and IVD registration in 100+ markets.Operon can help you obtain medical device approval and start selling in 100+ markets shown below.

Our Services

US FDA Registration Consultant

US FDA Registration Consultant

USFDA Certification Consultant and USFDA Registration consultant for medical device manufacturers Industry

ISO 13485 Consultant

ISO 13485 Consultant

ISO 13485 is a quality management system specifically developed for medical devices & related services.

ISO 15378 Consultant

ISO 15378 Consultant

We help to manufacturers For develop their quality management system as per the ISO 15378 requirements.

CDSCO Import License & Wholesale Registration

CDSCO Import License & Wholesale Registration

We help to manufacturers For develop their quality management system as per the ISO 15378 requirements.

Sector We Work

Medical Device Manufacturing Industry

Medical Devices are highly regulated products & different countries have a different regulatory approach for market clearance & sale of medical devices. Medical device vary in size, ease of use, safety ranging from simple bandages, surgical instruments to implants & complex systems involving software.

Primary Packaging Manufacturing Industry

Primary packaging material is defined as the material that that may or may not be in direct contact with the dosage form.Primary packaging may comprise any single part of a container closure system including containers, container liners, closures, closure liners, stopper oversells, etc.

Our Project

  • All
  • ISO 13485 Consultant
  • US FDA Consultant
  • ISO 15378 Consultant
  • GMP Guideline
  • CE Marking Consultant
 ANVISA Registration ANVISA Registration
iso 13485 Consultant iso 13485 Consultant
usfda registration
us fda registration us fda registration
ISO 15378 Consultant
ISO 15378 Consultant iso 15378 Consultant
CE Marking procedure.html
GMP Guideline GMP Guideline
CE Marking procedure.html
 CE Marking Consultant CE Marking Consultant
21 cfr part 210 and 211
21 cfr part 11 21 cfr part 11

Our Testmonials