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Overview of QMS System For Medical Devices

What Is (QMS) Quality Management System for Medical Devices? A (QMS) Quality Management System for medical devices is a systematic system for documenting the procedures and processes that are implemented throughout a medical device’s lifecycle. It can include medical device design, production, supplier management, product labeling, storage and distribution, clinical data, risk management, and complaint […]

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EU MDR Implementation

EU MDR Implementation

EU MDR Implementation: An Overview The European Union Medical Device Regulation (EU MDR) indeed represents a substantial shift in the regulatory landscape for medical device manufacturers, importers, distributors, and authorized representatives within the European market. This regulation, implemented on May 26th, 2021 (delayed from the original date of May 26th, 2020), is a significant overhaul

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Medical face mask classification

Medical face mask classification

Medical face mask classification to prevent germs from their noses and mouths from passing to the patient as well as to protect them from infection. The scrubs and gowns they wear serve similar purposes, protecting healthcare workers as well as patients from the accidental transmission of disease, as do the drapes that are used during

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Hand Sanitizer manufacturing

Hand Sanitizer Manufacturing process and Machines

Why Hand Sanitizer Manufacturing is a Growing Opportunity The demand for hand sanitizers skyrocketed during the COVID-19 pandemic and continues to remain high due to heightened hygiene awareness globally. For manufacturers, entrepreneurs, and startups, hand sanitizer production is not only a scalable business but also an essential healthcare solution. However, creating high-quality hand sanitizer requires

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EU Medical Device Regulation

EU Medical Device Regulation

EU Medical Device Regulation: An overview The EU Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. It is to have a fundamental revision in 2017 to better identify medical devices products and improve transparency through standard data, technological advances and the establishment

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N-95 masks and gowns FDA registration

N-95 masks and gowns FDA registration

About N-95 Masks and Gown N-95 masks and gowns FDA registration (including cloth face coverings), surgical masks, and respirators (filtering face piece respirators, intended for a medical purpose to assist in preventing the spread of infectious materials during the COVID-19 pandemic. Powered respirators, such as powered air purifying respirators (PAPRs), Face shields, Non-health care use

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CE Marking for Surgical Face Mask

Surgical Face Mask CE Marking

Surgical Face Mask CE Marking and EU Registration is mandatory for marketing the medical device in the European region. The present European Medical Device Directive (MDD) has to be followed with regard to Class 1 medical devices. As requirement of EU market these product should have CE mark  and as CE  mark medical device consultant

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Quality Management Plan

How Is a Quality Management Plan Implemented?

The Quality Management Plan outlines the information needed to properly manage project quality from planning to delivery. It outlines a project’s quality policies, procedures, criteria, application areas, roles, duties, and authority. Quality refers to how well a project meets its requirements. The Quality Management Plan describes how quality will be handled throughout the project’s lifecycle.

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the use of robotics improved medical device

Has the use of robotics improved medical device manufacturing?

Most recently the COVID-19 pandemic the use of robotics improved medical device manufacturing. Today, robotic automation is integrated into nearly every facet of medical device processing and production. Overall, today’s automated work cells are already an integral facet of medical device manufacturing. The pandemic of 2020 has only reinforced the necessity to progress further toward

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