Anuradha Shaha

MBA Finance, Science graduate, SEO & Technical content writer, possesses keen research and influencing writing skills for more than a year.

blood pressure monitor

Manufacturing Requirements for Blood Pressure Monitor Devices and Regulatory Compliance

Blood Pressure Monitors an Overview:  One can accurately check their blood pressure using a blood pressure (BP) monitoring device. It consists of a pump, a sensor that measures air pressure, and an elastic cuff. When the cuff is put on the user’s left arm, the artery beneath it is controlled to contract and release. It’s […]

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MDCG notified body

MDCG 2023-2 Guidance: European Regulators Clarify MDR and IVDR Standard Fees

The European (MDCG) has issued new guidance on standard fees for the MDR and IVDR. MDCG published guidance on lists of standard fees Notified Body (NBs) must disclose regarding conformity assessment and certification services under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation. Articles 50 of MDR and 46 of IVDR

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European Commission

The EC Supports The Extension Proposal of Transition Period for Legacy Devices.

The Medical Devices Regulation (MDR) 2017/745’s Article 120.3 is applicable to legacy devices, and the European Commission has proposed a new proposal to extend the certification period for those devices. This suggestion follows the EPSCO meeting talks on the time period extension for older devices that were discussed in an earlier post. Pls click here

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Gujarat FDCA issuing registration certificate to medical device manufacturers

Gujarat FDCA Issuing Registration Certificate to Medical Device Manufacturers.

Gujarat FDCA news for Medical Device Manufacturers. The Gujarat Food and Drug Control Administration has begun issuing medical device Registration Certificate (RC) (MD-42) to medical device makers in the state as part of a smooth transition to the new medical device regime. It recently gave RCs to 30 members of the Ophthalmic Association, Ahmedabad, as

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X-ray machine manufacturing

Medical Device Registration Process for An X-Ray Machine Manufacturing in India

An Overview of X-Ray Machine Manufacturing: X-rays are a type of electromagnetic radiation used for medical imaging. They help examine internal structures by transmitting waves through the body and capturing images on film or digital systems. Commonly used to detect fractures and diagnose conditions like pneumonia, X-rays pass through non-metallic tissues, making them essential in

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FDA human factor guidance

FDA Human Factors Guidance: Framework For Human Factors Information In Device Submissions

Last week, the US Food and Drug Administration (FDA) released an update describing a risk-based methodology for what human factors data should be included in marketing submissions for medical devices. The framework explains how to choose the category for human factors submissions and what to include in a marketing submission based on that category. According

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