Risk Management of Medical Devices in Accordance with ISO 14971:2019

1 Comment / Regulatory Compliance Guide | By MedDev Experts, CE Marking, Medical Device Rule, US FDA / MedDev Experts

Risk Management of Medical Devices in Accordance with ISO 14971:2019 This article is to assist manufacturers of medical devices to identify the hazards associated with the medical device, including software as a medical device, and in vitro diagnostic medical devices to estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of […]

Risk Management of Medical Devices in Accordance with ISO 14971:2019 Read More »

CDSCO Device Master File by Meddev Expert

CDSCO Device Master File for Medical Device: Indian MDR 2017

2 Comments / CE Marking, Medical Device Rule, US FDA / MedDev Experts

CDSCO Device Master File for Medical Devices The Device Master File for Medical Devices is a comprehensive and confidential document to provide technical information about the products to regulatory authorities. This document serves as a critical reference during the regulatory review process, enabling authorities to assess the safety, effectiveness, and quality of the medical devices

CDSCO Device Master File for Medical Device: Indian MDR 2017 Read More »

various medical device symbols displayed in a banner

Essential Medical Device Symbols for Labeling: A Comprehensive Guide As Per ISO 15223-1

1 Comment / CE Marking, Medical Device Rule, US FDA / MedDev Experts

Essential Medical Device Symbols for Labeling: A Comprehensive Guide as per ISO 15223-1 Medical Device Symbols are essential for conveying vital information on medical devices. When deemed appropriate, symbols can be marked on the device, packaging, or associated documentation. Manufacturers must ensure the symbols are of a suitable size for clear legibility. Before implementing symbols,

Essential Medical Device Symbols for Labeling: A Comprehensive Guide As Per ISO 15223-1 Read More »

NDC Number Reservation

1 Comment / US FDA / MedDev Experts

FDA NDC Number Reservation Made Easy: A Comprehensive Guide to Drug Identification and Compliance FDA NDC Number Reservation: An overview All drug establishments must provide the Food and Drug Administration (FDA) with a list of all drugs they manufacture, prepare, propagate, compound, or process for commercial distribution. The FDA uses a unique, three-segment number called

NDC Number Reservation Read More »

Unique Device Identification (UDI)-How to Comply with FDA Guidelines

1 Comment / US FDA / MedDev Experts

Unique Device Identification (UDI): How to Comply with FDA Guidelines? How to Comply with the UDI Rules of FDA? The implementation of the Unique Device Identification (UDI) system brings significant advancements to the medical device industry. The FDA’s UDI Rule mandates the inclusion of a unique device identifier on medical device labels, facilitating enhanced traceability,

Unique Device Identification (UDI)-How to Comply with FDA Guidelines Read More »