Bots 'N Brains

We work as Research & Product Development partner to build select Medical Device technologies along with all necessary support from concept to commercialization

[Bots 'N Brains @BotsNBrains]

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[Bots 'N Brains @BotsNBrains]

The Coronavirus lockdown circumstance ahas made India focus more on medical device fabrication in India. Manufacturers have long requested the government to reduce GST on devices to 5 % from the current 18 %.
Read more at https://t.co/Yy8M4wnL8C

[Bots 'N Brains @BotsNBrains]

CDSCO is fundamentally answerable for guideline of medical devices. Manufacturers GMP and conduct reasonable tests to demonstrate the device quality.

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[Bots 'N Brains @BotsNBrains]

Medical devices in India has been divided into classes. The classes are named as Class A that includes devices of low danger, Class B as low moderate danger, Class C as moderate high danger, and Class D as high danger.

Read more at https://t.co/qtOuQo96OI

[Bots 'N Brains @BotsNBrains]

Medical device authorities need to ensure that clinical gadgets are as accurate as could reasonably be expected. But the idea of accomplishing and keeping up administrative consistence wory manufacturers.

Read more at https://t.co/tTSnDVE9HF

[Bots 'N Brains @BotsNBrains]

FDA has to ensure that medical devices are as protected as could reasonably be expected. Manufacturers need to pass all these regulation. And the idea of accomplishing and keeping up administrative consistence may wory some firms.

Read full article on https://t.co/c0165HROyZ

[Bots 'N Brains @BotsNBrains]

The Indian government has set out the timeline for moving to another administrative framework. Authorities plan to establish a law for the oversight of all devices. The change may increase the sales of medical devices in India

Read full article on https://t.co/FPhazlOiFE

[Bots 'N Brains @BotsNBrains]

India Medical Device Regulations and the Indian clinical administrative framework have gotten more confounded as of late. There are around 30 equipment "families" that layout which explicit medical equipment should be enlisted.
Read the full article on https://t.co/uP0kO5L19l

[Bots 'N Brains @BotsNBrains]

Disposable Syringes are being used by doctors to inject medicines through intravenous or intramuscular ways for the treatment of diseases & also by research & development personnel.
Read the full article on https://t.co/wJrN7aoMi8

[Bots 'N Brains @BotsNBrains]

In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health
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[Bots 'N Brains @BotsNBrains]

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies.
Read the full article on https://t.co/gxroodRLTD

[Bots 'N Brains @BotsNBrains]

Some products are designed specifically for children, while others are borrowed from adult applications or produced for more general use. Designing pediatric medical devices can be challenging
Read the full article on https://t.co/tZYzWSO0hc

[Bots 'N Brains @BotsNBrains]

The CAPA requirement applies to manufacturers of medical devices and compels them to include CAPA in their Quality Management System (QMS). CAPA is split between two distinct but related functions.
Read the full article on https://t.co/nnZOIzy2la

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Medical device software defines the Software life cycle processes. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.
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[Bots 'N Brains @BotsNBrains]

The most important goal of the human factors/usability engineering process is to minimize use-related hazards and risks and then confirm that these efforts were successful and users can use the device safely and effectively.
Read the full article on https://t.co/JAkR5ufSv9

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For an inventor, product prototype development is essential. After all, a product prototype is a physical manifestation of a mere idea, which can serve different purposes. To learn more about alpha and beta prototypes
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[Bots 'N Brains @BotsNBrains]

A patent is a monopoly right for an invention, which is used to carve out market exclusivity for a product. Patent protection is time-limited and in India this limit is for 20 years from the date of filing the patent application.
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The design history file shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

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[Bots 'N Brains @BotsNBrains]

Artificial intelligence (AI) has already revolutionized numerous industries, including healthcare. It is gaining pace and we can witness many innovations that seemed to be impossible a few years ago.
Read the full article on https://t.co/X68UIP5hS3

[Bots 'N Brains @BotsNBrains]

GE Healthcare won FDA clearance for its SIGNA 7.0T MRI scanner, currently the most powerful device available for clinical applications. This leads to high resolution, speedier scans, advanced diffusion, and functional MRI imaging.
Read the full article on https://t.co/xIJm0M9UeT

[Bots 'N Brains @BotsNBrains]

Clinical investigations regarding devices bearing the CE marking, refers to a post-market clinical follow-up investigation as a clinical investigation conducted to assess, a device which already bears the CE marking.
Read the full article on https://t.co/hlV5f91YvM