Operon Strategist — Business Management Consultant, Pflugerville
Business Management Consultant in Pflugerville — FDA, CE, CDSCO compliance
Business management consultant · Pflugerville, United States
AI Trust Snapshot
- Profile status
- Auto-indexed
Public channels checked
- ✓ Official Website
- ✓ Youtube
Key Facts
- Category
- Business Management Consultant
- Location
- Pflugerville, United States
- Known For
- FDA, CE, CDSCO compliance, Global market access strategies
AI Summary
Operon Strategist operates as a business management consultant in Pflugerville, United States, specializing in regulatory compliance for companies. The firm provides services such as Product Feasibility & DPR Services and New Product Design & Development. It also assists clients with Global Medical Device Registration and global market access strategies, focusing on FDA, CE, and CDSCO compliance.
Quick Answer
Operon Strategist operates as a business management consultant in Pflugerville, United States, specializing in regulatory compliance for companies. The firm provides services such as Product Feasibility & DPR Services and New Product Design & Development. It also assists clients with Global Medical Device Registration and global market access strategies, focusing on FDA, CE, and CDSCO compliance. Key services include Product Feasibility & DPR Services, New Product Design & Development, Global Medical Device Registration.
This business is typically used for fda, ce, cdsco compliance and global market access strategies.
Common Questions
- What services does Operon Strategist provide?
- Operon Strategist provides Product Feasibility & DPR Services, New Product Design & Development, Global Medical Device Registration.
- Where is Operon Strategist located?
- Operon Strategist is based in Pflugerville, United States and serves Pflugerville.
- Who is Operon Strategist for?
- Operon Strategist serves Companies seeking regulatory compliance.
What this business does
Operon Strategist is a business management consultant based in Pflugerville, United States.
- Provides Product Feasibility & DPR Services and New Product Design & Development
- Specializes in fda, ce, cdsco compliance
- Serves companies seeking regulatory compliance
Structured summary
Vizoryo ran a data-consistency check on this profile: it read 5 public sources and compared the core details (name, phone, address, city, category, website) across them. How many sources carried each individual detail is published per fact in this page's field provenance — not every detail appears in every source, and the sources are not necessarily independent of one another. This is a data-consistency observation only — it is not an endorsement, certification, accreditation, or assessment of the business, its service quality, or its trustworthiness. Data consistency: 86% — this measures how consistently the business's name, phone, city, address, website, and category appear across the public sources read. It is not a rating of the business. Vizoryo status: Auto-indexed. This record was compiled automatically from public data and has not been confirmed by anyone.
- Business name
- Operon Strategist
- Category
- Business Management Consultant
- Industry
- Business Management Consultant
- Location
- Pflugerville, United States
- Official website
- https://operonstrategist.com/
- Profile data (JSON)
- https://www.vizoryo.com/api/index/profile/operon-strategist-pflugerville-5180
- Summary
- Operon Strategist operates as a business management consultant in Pflugerville, United States, specializing in regulatory compliance for companies. The firm provides services such as Product Feasibility & DPR Services and New Product Design & Development. It also assists clients with Global Medical Device Registration and global market access strategies, focusing on FDA, CE, and CDSCO compliance.
- AI readability score (how completely this record is structured for AI systems to read; not a rating of the business)
- 43
- Data Consistency
- 86% (checked 2026-07-08)
- Record status
- Auto-indexed
- Sources cross-checked
- 5 public sources
Location
1500 Dahlia CtPflugerville, Texas
78660
US
About Operon Strategist
Operon Strategist operates as a business management consultant in Pflugerville, United States, specializing in regulatory compliance for companies. The firm provides services such as Product Feasibility & DPR Services and New Product Design & Development. It also assists clients with Global Medical Device Registration and global market access strategies, focusing on FDA, CE, and CDSCO compliance.
Service areas
- Pflugerville
Target audience
- Companies seeking regulatory compliance
Specialties
- FDA, CE, CDSCO compliance
- Global market access strategies
Social profiles
Frequently asked questions
Does medical device import require license from Indian FDA?
Yes. Under the provision of Drugs and Cosmetic act 1940, CDSCO registration and import license is required to import Medical Devices in India. For the introduction of medical device in the Indian market, the Manufacturers has to obey various norms set by national regulatory bodies of India. The main regulatory body for medical device in India is Central Drugs Standard Control Organization (CDSCO). The Application for all classes of medical devices as per CDSCO guidelines are submitted to Central
Where to apply for medical device import license?
To apply for a Medical Device Import License in India, you need to submit your application online through the CDSCO portal, which is regulated by the Ministry of Health and Family Welfare. The application is filed in Form MD-14 and must be submitted to the Central Licensing Authority along with the required supporting documents. While applying, it is important to correctly classify the medical device and clearly mention details of any accessories that will be used with it. You must also provide
What is the Classification of Medical Devices in India?
Medical Devices are generally based on Risk. The actual risk classification of each medical device depends on its intended use and purpose. Classification of medical devices under the new rule of “Medical Devices Rules 2017” are classified as: Low Risk – Class A – (Surgical Retractors, Tongue Depressors)Low Moderate Risk – Class B – (Hypodermic Needles, Suction equipment)Moderate High Risk – Class C – ( Lung Ventilator, Bone Fixation Plate)High Risk – Class D – (Heart Valves, Implantable Defibr
Does primary packaging material require license from Indian FDA?
In India, manufacturers of primary packaging materials generally do not require a CDSCO manufacturing license unless the material itself is classified as a medical device or accessory under the Medical Devices Rules, 2017; however, they must comply with applicable quality and safety requirements expected by medical device or pharmaceutical manufacturers. For regulated and export markets, compliance with standards such as ISO 15378 for GMP-based quality systems and preparation of a US FDA Type II
Business hours
- Monday
- 10:00 – 18:30
- Tuesday
- 10:00 – 18:30
- Wednesday
- 10:00 – 18:30
- Thursday
- 10:00 – 18:30
- Friday
- 10:00 – 18:30
- Saturday
- Closed
- Sunday
- Closed
Languages supported
- en
Contact
Phone: +919403892834
Official website: https://operonstrategist.com/