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Meeraoperon's Blog (218)

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Selection of a Notified Body and Their Process for your new device authority

Notified Bodies an overview:



A Notified Body is a third-party organization that has been approved by an EU member state to judge whether manufacturers adhere to the relevant legislation. With such a crucial role, choosing a Notified Body and your partnership’s working relationship are crucial to getting your CE marking. As CE marking medical device consultant, we know the criticality of selecting the Notified body and hence we work with right notified bodies to get the… Continue

Added by meeraoperon on August 9, 2022 at 6:24am — No Comments

FDA 510k clearance barriers

A FDA 510k clearance or premarket submission demonstrates that the device which is marketed is safe and effective as predicate. The FDA 510k process is necessary to enter into the US market / or to sell your device in the US market. The FDA is responsible for authoring and enforcing the medical device quality system regulations (QSR), found in 21 CFR Part 820 of the Code of Federal Regulations. The FDA 510 k clearance process is the most common pre-market pathway for medical device companies.… Continue

Added by meeraoperon on July 29, 2022 at 6:35am — No Comments

Top challenges & opportunities for medical device market

The Medical device market looks positive and shows steady growth. Be a part of huge and growing medical device market.

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

Visit- https://operonstrategist.com/challenge-opportunities-medical-device-market/

Added by meeraoperon on May 4, 2022 at 7:44am — No Comments

what should trigger a CAPA

CAPA is acronym of Corrective Action and Preventive Action. The CAPA process is one of the center cycles that exist inside the quality arrangement of every medical device organization.

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

Visit- https://operonstrategist.com/what-should-trigger-a-capa/

Added by meeraoperon on May 4, 2022 at 7:37am — No Comments

Active implantable medical devices

For the regulations of active implantable devices operon strategist can provide valuable guidance, Active implantable medical devices are devices which depend on other sources of energy.

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

Visit- Active implantable medical devices (operonstrategist.com)

Added by meeraoperon on April 28, 2022 at 6:46am — No Comments

UKCA marking for medical devices

For a product or medical device to be placed in GB market UKCA marking is mandatory from June30,2023. A UKCA mark is a logo that is put on medical device to show they adjust to the prerequisites in the UK MDR 2002.



Contact details –



Phone no - 93702 83428



Mail id – [email protected]



Visit-… Continue

Added by meeraoperon on April 28, 2022 at 5:41am — No Comments

CDSCO Import License for Medical Devices

Operon Strategist is a medical device consulting company. We assists medical device distributors and medical device wholesalers in India to procure CDSCO import licenses.

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

Visit- https://operonstrategist.com/cdsco-import-license-medical-device/

Added by meeraoperon on April 23, 2022 at 5:41am — No Comments

Turnkey Project Consultants

Operon provide consultant service turnkey project to the manufacturer.



Contact details –



Phone no - 93702 83428



Mail id – [email protected]



Visit-… Continue

Added by meeraoperon on April 23, 2022 at 5:33am — No Comments

ISO 11137-Gamma Sterilization Validation

ISO 11137 governs with the use of radiation to sterilize healthcare product.



Contact details –



Phone no - 93702 83428



Mail id – [email protected]



Visit-… Continue

Added by meeraoperon on April 22, 2022 at 6:09am — No Comments

FDA Review Process For 510k Medical Device Submissions

FDA Review process for 510k of medical device submission is important to sell medical device in US market.



Contact details –



Phone no - 93702 83428



Mail id – [email protected]



Visit-… Continue

Added by meeraoperon on April 22, 2022 at 5:59am — No Comments

European standard for risk management of medical devices is amended - EN ISO 14971 2020

This article will deal with some changes and suggestions in amendments of EN ISO 14971 2019

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

Visit- EN ISO 14971 2019

Added by meeraoperon on April 6, 2022 at 7:57am — No Comments

European standard for risk management of medical devices is amended - EN ISO 14971 2020

This article will deal with some changes and suggestions in amendments of EN ISO 14971 2019

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

Visit- https://operonstrategist.com/en-iso-14971-2019/?utm_source=classified&utm_medium=classified&utm_campaign=classified

Added by meeraoperon on April 6, 2022 at 7:30am — No Comments

CDSCO Registration FAQs  - Operon Strategist

Operon Strategist is Medical Device Consulting. we can assist the manufacturer in the process of cdsco registration.

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

Visit-…

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Added by meeraoperon on April 1, 2022 at 5:43am — No Comments

Medical Device Manufacturing consultant

Operon Strategist is Medical Device Consulting. we can assist the manufacturer in the process of cdsco registration.

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

Visit-…

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Added by meeraoperon on April 1, 2022 at 5:37am — No Comments

Medical Device Manufacturing consultant

Operon Strategist is Medical Device Consulting. we can assist the manufacturer in the process of cdsco registration.

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

Visit-…

Continue

Added by meeraoperon on April 1, 2022 at 5:37am — No Comments

Medical Device Manufacturing consultant

Operon Strategist are medical device consulting. We can assists companies and medical device manufacturers by providing consultancy services

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

Visit-…

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Added by meeraoperon on April 1, 2022 at 5:05am — No Comments

Medical Device Manufacturing consultant

Operon Strategist are medical device consulting. We can assists companies and medical device manufacturers by providing consultancy services

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

Visit-…

Continue

Added by meeraoperon on April 1, 2022 at 5:05am — No Comments

TURNKEY PROJECT CONSULTANTS

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]

Visit-…

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Added by meeraoperon on March 30, 2022 at 6:28am — No Comments

TURNKEY PROJECT CONSULTANTS

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]

Visit-…

Continue

Added by meeraoperon on March 30, 2022 at 6:28am — No Comments

TURNKEY PROJECT CONSULTANTS

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]

Visit-…

Continue

Added by meeraoperon on March 30, 2022 at 6:28am — No Comments

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