Regulatory Approvals and Certification
Medical Device Consulting
Operon Strategist is a medical device quality consulting company which provides regulatory guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications. We provide the clients customized solutions to manufacturers looking to set up a world-class manufacturing unit.
Our global presence caters to clients from around the globe & includes small start-ups to world’s renowned medical device manufacturers. We have a team of experts whose knowledge & experience helps them handle clients both small & large.
Our Services
FDA 510 k Clearance
We are a Bunch of Regulatory Professionals & Experts in FDA 510 k clearance
CDSCO Registration
When it comes to CDSCO medical device license process, Operon strategist makes the lengthy process easy and smooth.
Medical Device CE Mark
We help you in the process of making a defined and comprehensive technical file with all product details required for CE marking.
We provide medical device regulatory consulting services for Turnkey Project that includes Facility layout design, Regulatory support for Clean Room,…
ISO 13485 Consultant provides Guidance for medical device manufacturers for obtaining ISO 13485 certification Quality Management System
Combination Product approval from FDA. Drug Device Combination Products is the combination of two or more drugs and medical device. ISO 13485:2016
With the expertise in regulatory affairs and quality management systems, we monitor facilities…
Medical Device Design and Development
Medical Device Design and Development plays a vital role in making the medical device. This is the most important stage in the medical device development
21 cfr part 820 (QSR)
FDA 21 CFR Part 820 Quality System Regulation Consultant Services For Medical Device Manufacturers.
Design Control Requirements
US FDA 21 CFR 820.30 Design Control Requirements for medical device design. Design Control Guidance For Medical Device Manufacturers
Medical Device Manufacturing
Operon Strategist is an expert Medical Device manufacturing consultancy providing registration support for Medical Equipment manufacturing in India.
