Operon Strategist is a medical device regulatory consulting company which provides regulatory advisory & guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.

Contact details –

Phone no - 9325283428

Mail id – dm@[email protected]

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With advancing medical technology, the medical device market is expected to grow over the next several years due to increased health awareness, a growing middle class, and government health initiatives. The medical device registarion process in India is overhauled in 2017 with the publication of the Medical Device Rules.

The rules came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health…

With advancing medical technology, the medical device market is expected to grow over the next several years due to increased health awareness, a growing middle class, and government health initiatives. The medical device registarion process in India is overhauled in 2017 with the publication of the Medical Device Rules.

The rules came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health…

A medical device is a gadget, material, software or an apparatus which can be used alone or in combinations, including the product proposed by the medical device manufacturer to be utilized particularly for diagnostic or potentially for therapeutic purposes. And required for its proper application, planned by the Medical Device manufacturers to be utilized for people. Medical devices differ as per their planned use and indication. For example, medical devices like tongue depressors, medical…

Emerging Medical Device Manufacturers is expected to grow by leaps and bounds owing to the rising aging population, increasing health concerns, and sky-rocketing health care costs. As a result, medical device manufacturers are undertaking new product development projects at breakneck speed, especially in the emerging markets.

Emerging companies face unique challenges. Those who are at or near FDA approval are at the point of commercialization, and this means significant change is at…

Emerging Medical Device Manufacturers is expected to grow by leaps and bounds owing to the rising aging population, increasing health concerns, and sky-rocketing health care costs. As a result, medical device manufacturers are undertaking new product development projects at breakneck speed, especially in the emerging markets.

Emerging companies face unique challenges. Those who are at or near FDA approval are at the point of commercialization, and this means significant change is at…

Emerging Medical Device Manufacturers is expected to grow by leaps and bounds owing to the rising aging population, increasing health concerns, and sky-rocketing health care costs. As a result, medical device manufacturers are undertaking new product development projects at breakneck speed, especially in the emerging markets.

Emerging companies face unique challenges. Those who are at or near FDA approval are at the point of commercialization, and this means significant change is at…

The European Authorized Representative for medical devices is assigned a pivotal role in the CE Marking process. If you don’t have one, you can simply not sell your products within the European Union. The European legislation stipulates the role of a European Authorized Representative Authorized Representative for medical devices, also known as EU Auth. Rep., EC Rep or AR, for manufacturers who don’t have their own location in Europe. EU Authorized Representatives act on behalf of…

The European Authorized Representative for medical devices is assigned a pivotal role in the CE Marking process. If you don’t have one, you can simply not sell your products within the European Union. The European legislation stipulates the role of a European Authorized Representative Authorized Representative for medical devices, also known as EU Auth. Rep., EC Rep or AR, for manufacturers who don’t have their own location in Europe. EU Authorized Representatives act on behalf of…

The European Authorized Representative for medical devices is assigned a pivotal role in the CE Marking process. If you don’t have one, you can simply not sell your products within the European Union. The European legislation stipulates the role of a European Authorized Representative Authorized Representative for medical devices, also known as EU Auth. Rep., EC Rep or AR, for manufacturers who don’t have their own location in Europe. EU Authorized Representatives act on behalf of…

The European Authorized Representative for medical devices is assigned a pivotal role in the CE Marking process. If you don’t have one, you can simply not sell your products within the European Union. The European legislation stipulates the role of a European Authorized Representative Authorized Representative for medical devices, also known as EU Auth. Rep., EC Rep or AR, for manufacturers who don’t have their own location in Europe. EU Authorized Representatives act on behalf of…

In vitro diagnostics for COVID-19 testing has come to demand due to the spread of the deadly virus. The demand for molecular testing, regarded as the gold standard for diagnosing infectious disease, has exploded. While the disease remains uncontained, such demand is likely to keep growing. Meanwhile, the rush to meet it has already driven four main developments in the IVD industry

The highly contagious nature of this respiratory disease challenges advanced viral In vitro diagnostics…

In vitro diagnostics for COVID-19 testing has come to demand due to the spread of the deadly virus. The demand for molecular testing, regarded as the gold standard for diagnosing infectious disease, has exploded. While the disease remains uncontained, such demand is likely to keep growing. Meanwhile, the rush to meet it has already driven four main developments in the IVD industry

The highly contagious nature of this respiratory disease challenges advanced viral In vitro diagnostics…

Phases of CDSCO Manufacturing license

Phase I – Applicant Registration

Phase II – Test License application

Phase III – Manufacturing license application

Pre-requisite:

Generic Name / Brand Name

Intended Use

Material of construction

Mode of application

Phase I – Applicant Registration:

In thisphase after applying client can have an active account on CDSCO Online System for Medical Devices registration site.

Document…

Phases of CDSCO Manufacturing license

Phase I – Applicant Registration

Phase II – Test License application

Phase III – Manufacturing license application

Pre-requisite:

Generic Name / Brand Name

Intended Use

Material of construction

Mode of application

Phase I – Applicant Registration:

In thisphase after applying client can have an active account on CDSCO Online System for Medical Devices registration site.

Document…

Ct scan equipment manufacturing counted amongst the prominent CT Scan Machine. A CT scanner emits a series of narrow beams through the human body as it moves through an arc. This is different from an X-ray machine, which sends just one radiation beam. The CT scan produces a more detailed final picture than an X-ray image.

Ct scan equipment manufacturing is very capital intensive and requires extensive support infrastructure. Most companies buy the tubes, detectors and magnets from…

In the 21 CFR Part 210 and 211, 21 CFR Part 210 deals with the Manufacturing, Processing, Packaging or Holding of drugs, while 21 CFR Part 211 deals with finished pharmaceuticals. This cGMP Guidance related to the pharmaceutical and drug-related industry.

21 CFR Part 210 and 211

The move was in response to concerns about substandard drug manufacturing practices at the time. The 1962 Drug modification brought modern quality assurance and control principles to drug manufacturing. The…

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…