The regulatory procedures for medical device manufacturing vary according to their classes. These are importing, registering, licensing and clinical trials in India.
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The regulatory procedures for medical device manufacturing vary according to their classes. These are importing, registering, licensing and clinical trials in India.
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Phone no - 93702 83428
Mail id – [email protected]
Visit- https://operonstrategist.com/medical-device-manufacturing/

Classifying a Class III Medical Device
Classifying a Class III Medical Device the FDA established certain regulatory controls in the form of general controls and special controls..
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Import of oxygen concentrator has now been waived by the Customs duty and the health cess for three months on the import of medical oxygen and a slew of equipment related to production of the gas.
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Risk Benefit Analysis is a comparison between the risks of a situation and its benefits. The goal is to figure out whether the risk or benefit is most significant.
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Disposable masks manufacturing is done with the goal that it very well may be utilized as a defensive hindrance to forestall cross-sullying among patients and specialists
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Oxygen equipment manufacturing kits are supplied as either a Standard kit, or a Dive Tender kit. Oxygen is one of the basic chemical elements

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Preventing spread of infection relies on effective use of Disposable Medical Gowns from the coronavirus disease 2019 (COVID-19). With increasing awareness about the highly communicable bacteria and viruses, medical professionals and associations are making it mandatory to use protective Disposable Medical Gowns to barrier the spreading of various diseases like SARS, HIV, hepatitis, etc.

These diseases, which may be caused by a variety of microorganisms, can pose significant risks to…

Central Drugs Standard Control Organization, commonly known as CDSCO is a regulatory body for the Indian medical devices industry, under regulatory provisions of the Drugs & Cosmetics Act 1940 & Rules 1945. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian medical devices and pharmaceuticals. It is a licensing authority which approves any new chemical entity (drug) to import to India. Every nation in the world has its own dedicated…

Central Drugs Standard Control Organization, commonly known as CDSCO is a regulatory body for the Indian medical devices industry, under regulatory provisions of the Drugs & Cosmetics Act 1940 & Rules 1945. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian medical devices and pharmaceuticals. It is a licensing authority which approves any new chemical entity (drug) to import to India. Every nation in the world has its own dedicated…

Disposable Medical device manufacturing or single-use medical devices are medical devices or any medical apparatus or instrument which has the capacity of being used only for once or which has one time use. Disposable devices are used in hospital or healthcare sectors and then after used is been disposed of. The FDA defines that this device is entitled by the manufacturer and the intended use for this medical device is for one single patient and one procedure only. This means that the device…

Medical Device CE Mark is a Certification mark for Health, Safety and Environment protection standards to sell medical products in EEA (European Economic Area), CE mark is recognized worldwide. CE Mark is a declaration by manufacturers that, the products they are sell in EEA are meeting the requirements of EC Directives. In order to market products in the European market, the products must have a CE mark which declares that a product meets all relevant European Medical Device…

Remote Patient Monitoring Devices has emerged as the next significant challenge for virtual healthcare and that challenge is creating significant opportunities for many companies largely outside of the traditional healthcare technology marketplace. In an age when nearly everyone is digitally connected in some way – even many senior citizens, who are often characterized as technophobic – it only makes sense that the healthcare industry is seeing a lot of connected health…

Remote Patient Monitoring Devices has emerged as the next significant challenge for virtual healthcare and that challenge is creating significant opportunities for many companies largely outside of the traditional healthcare technology marketplace. In an age when nearly everyone is digitally connected in some way – even many senior citizens, who are often characterized as technophobic – it only makes sense that the healthcare industry is seeing a lot of connected health…

Remote Patient Monitoring Devices has emerged as the next significant challenge for virtual healthcare and that challenge is creating significant opportunities for many companies largely outside of the traditional healthcare technology marketplace. In an age when nearly everyone is digitally connected in some way – even many senior citizens, who are often characterized as technophobic – it only makes sense that the healthcare industry is seeing a lot of connected health…

Disposable Medical device manufacturing or single-use medical devices are medical devices or any medical apparatus or instrument which has the capacity of being used only for once or which has one time use. Disposable devices are used in hospital or healthcare sectors and then after used is been disposed of. The FDA defines that this device is entitled by the manufacturer and the intended use for this medical device is for one single patient and one procedure only. This means that the device…

Medical Tubing is used for fluid management and drainage as well as with anesthesiology and respiratory equipment, IVs, catheters, peristaltic pumps, and bio-pharmaceutical laboratory equipment. What sets Medical Tubing apart from other types of tubing is its designation for medical applications.

This designation typically comes through standards or certifications which dictate material and specification requirements for tubes. These requirements are in place to ensure that the…

Identifying the PRRC for your company is a most important requirement that applies to the European Union and is a core area of responsibility for a person or persons under the Medical device regulation, or In vitro device regulation . The directive to appoint the PRRC also depends on the size of the organization. This is mandatory requirement for any CE Marking under the new EU MDR

The motivation for Identifying the PRRC positions is so that there is a qualified regulatory expert…

Identifying the PRRC for your company is a most important requirement that applies to the European Union and is a core area of responsibility for a person or persons under the Medical device regulation, or In vitro device regulation . The directive to appoint the PRRC also depends on the size of the organization. This is mandatory requirement for any CE Marking under the new EU MDR

The motivation for Identifying the PRRC positions is so that there is a qualified regulatory expert…

The Covid-19 antigenic test may be presented as a quick and useful opportunity to reduce transmission of the virus.

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