Meeraoperon's Blog – October 2021 Archive (12)

N-95 masks and gowns FDA registration

The N-95 masks and gowns FDA registration is collaborating with manufacturers of surgical masks and gowns to better understand the current supply chain issues related to the COVID-19 outbreak, and to avoid any widespread shortages of these products.

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

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Added by meeraoperon on October 29, 2021 at 5:42am — No Comments

FDA medical device approval process step-by-step guide

FDA medical device approval process. Also read about How long does it take for FDA to approve a medical device?
Contact details –
Phone no - 93702 83428
Mail id – [email protected]
Visit- https://operonstrategist.com/fda-medical-device-approval-process/

Added by meeraoperon on October 27, 2021 at 8:02am — No Comments

N-95 masks and gowns FDA registration

The N-95 masks and gowns FDA registration is collaborating with manufacturers of surgical masks and gowns to better understand the current supply chain issues related to the COVID-19 outbreak, and to avoid any widespread shortages of these products.

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

Visit-…

Continue

Added by meeraoperon on October 23, 2021 at 5:02am — No Comments

FDA Design And Development Planning

FDA Design And Development Planning is To ensure that good quality assurance practices are used for the design of medical devices.

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

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Added by meeraoperon on October 20, 2021 at 5:34am — No Comments

Certificate to foreign government FDA

Certificate to foreign government FDA is required by many medical device market regulators in Asia, the Middle East, and Latin America in order to legally sell your product in their territories.

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

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Added by meeraoperon on October 20, 2021 at 5:04am — No Comments

US FDA ramping up permanent 510(k)

US FDA ramping up permanent 510(k) on Monday finalized guidance explaining when it considers micro needling devices to be medical devices subject to premarket notification (510(k)) requirements.

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

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Added by meeraoperon on October 20, 2021 at 4:48am — No Comments

fda medical device classification

The US FDA’s classification guidelines can be highly confusing to medical device manufacturers with limited exposure to the system.

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Phone no - 93702 83428

Mail id – [email protected]

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Added by meeraoperon on October 13, 2021 at 3:18am — No Comments

CDSCO Guideline Approved for Medical Devices Safety & Performance

CDSCO guideline approved under the Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.

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Phone no - 93702 83428

Mail id – [email protected]

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Added by meeraoperon on October 13, 2021 at 3:09am — No Comments

Better Insights For ISO 13485 2016 Validation Requirements

ISO 13485: 2016, organizations had been obligated to look in for transition in QMS being used.

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Phone no - 93702 83428

Mail id – [email protected]

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Added by meeraoperon on October 13, 2021 at 2:57am — No Comments

CDSCO Classification for medical devices

The CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

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Added by meeraoperon on October 7, 2021 at 6:55am — No Comments

Validation Master Plan

validation master plan (VMP) diagrams the standards associated with the capability of an office, characterizing the areas and systems to be approved

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Phone no - 93702 83428

Mail id – [email protected]

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Added by meeraoperon on October 7, 2021 at 6:29am — No Comments

MDD to New MDR Classification of Medical Devices

The prerequisites for MDR classification for medical devices are basically equivalent to those in the present Medical Devices Directive (MDD).

Contact details –

Phone no - 93702 83428

Mail id – [email protected]

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Added by meeraoperon on October 7, 2021 at 6:05am — No Comments

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