As Turnkey Project Consultants, we work on complex technical problems and guide in planning the medical device manufacturing plant layout which is to reduce the client’s costs and the effort for observing, individual coordination and planning to a minimum.

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As Turnkey Project Consultants, we work on complex technical problems and guide in planning the medical device manufacturing plant layout which is to reduce the client’s costs and the effort for observing, individual coordination and planning to a minimum.

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

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Economic operator As per MDR / IVDR economic operator means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Articles 22(1) and 22(3). 

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Phone no - 93702 83428

Mail id – [email protected]

Visit- https://operonstrategist.com/eu-mdr-economic-operator/

Economic operator As per MDR / IVDR economic operator means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Articles 22(1) and 22(3). 

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Phone no - 93702 83428

Mail id – [email protected]

Visit- https://operonstrategist.com/eu-mdr-economic-operator/

Economic operator As per MDR / IVDR economic operator means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Articles 22(1) and 22(3). 

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Phone no - 93702 83428

Mail id – [email protected]

Visit- https://operonstrategist.com/eu-mdr-economic-operator/

This Article explains QMS perspective for drug device combination for a manufacturing company

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Operon Strategist assists companies and medical device manufacturers by providing consultancy services that support the registration of drug-device Combination Products.

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This article will brief us with information of CDSCO registration process, CDSCO registration fees, CDSCO registration of medical devices and more.

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The below content spread a light on the process of Medical device Registration in Australia. To enter into the Australian market For any medical device manufacturing firm the first necessary step is to get listed with Australian Register of Therapeutic Goods (ARTG).

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The below content spread a light on the process of Medical device Registration in Australia. To enter into the Australian market For any medical device manufacturing firm the first necessary step is to get listed with Australian Register of Therapeutic Goods (ARTG).

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Phone no - 93702 83428

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For a manufacturer it is very expensive to recall their product. Few products are recalled because of their serious side effect, medical device recall is for the safety of public heath.

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For a manufacturer it is very expensive to recall their product. Few products are recalled because of their serious side effect, medical device recall is for the safety of public heath.

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Phone no - 93702 83428

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For a manufacturer it is very expensive to recall their product. Few products are recalled because of their serious side effect, medical device recall is for the safety of public heath.

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Operon Strategist are expert FDA 510 k consultants for Medical Devices. We assist Medical Device manufacturers with FDA 510 k Clearance and Premarket approval. Call us today.

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This particular blog speaks about Quality management system regulation (QSMR)

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This particular blog speaks about Quality management system regulation (QSMR)

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Phone no - 93702 83428

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This particular blog speaks about Quality management system regulation (QSMR)

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Phone no - 93702 83428

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FDA is an agency within the US health and welfare department, a regulatory body which provides some guideline for setting up the plants of medical devices. FDA registration FAQs

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FDA is an agency within the US health and welfare department, a regulatory body which provides some guideline for setting up the plants of medical devices. FDA registration FAQs

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Phone no - 93702 83428

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As per the new guidelines of every medical device manufacturer should have a PRRC within their organization. Article 15(A) outlines the roles of PRRC.

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