QMS Certification Services

Quality Management Systems (QMS) certification is the requirement of every business processes who need to comply with an arrangement of complex and challenging regulatory requirements. Operon Strategist has substantial experience in regulatory areas required for QMS certification implementation of medical devices, in vitro diagnostic devices, packaging material products, pharmaceuticals products and combination products.

QMS certification service including QMS certification training, layout designs, manufacturing and postmarket support as we have regulatory expertise in auditing, executing and maintaining all features. Our team involves in former U.S. FDA, EU notified body, QMS certification body and Medical Devices Agency professionals with the well built technical expertise to assist and protect your quality systems that can follow with the toughest regulatory inspection.

We Provide Following QMS Certification Services For Manufacturers:

US FDA 21 CFR Part 820 Quality system regulation

US FDA 21 Part 820 covers the processes used in, and the facilities and controls used for the design, manufacture, packaging, labelling, storage, installation and servicing medical devices.

21 CFR Part 210 and 211 Quality Assurance

21 CFR Part 210 and 211 deals with the Manufacturing, Processing, Packaging or  Holding of drugs, and pharmaceuticals.

ISO 13485 Certification

ISO 13485 certification specifies requirements for a Quality Management System (QMS) certification where an organization needs to demonstrate its ability to provide medical devices.

ISO 15378 Certification

ISO 15378 Certification is QMS certification for primary packaging materials for medicinal products particular requirements for the application of ISO 9001:2008, with reference to GMP.

Drug Master File (DMF)

The  Drug Master File (DMF) is a document that is prepared by the medical device maker/manufacturer, in which he/she provides confidential information about the product to USFDA.

US FDA 510(k)

The process 510(k) is a premarket approval made for FDA to signify that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a lawfully marketed device that is not subject to premarket approval

CDSCO Guidelines

Central Drugs Standard Control Organization (CDSCO) regulates the Medical device industry in India under the regulatory provisions of the Drugs & Cosmetics Act 1940 & Rules 1945.

CE Marking Certification

CE marking certification is regulatory approval for the European market. The products having a CE mark which declares that a product meets the all relevant European Medical Device Directives.

Get Register QMS Certification For Your Product

Our Other Services

Manufacturing Site Design and Conceptualization

Regulatory Compliances

Medical Device/Drug-Device Combination Product Design & Development

Medical Device Post Marketing Support

Meet Our Clients

Post Marketing Surveillance, QMS certification, medical device consultant, medical device regulatory consultant, turnkey project consultant, Manufacturing Site Design, Medical Device Design and Development,
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