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Top 3 Medical Device Security Challenges and solution

Top 3 Medical Device Security Challenges and Solution

Medical device businesses have been able to develop devices that provide better treatments, more precise diagnoses, increased data reporting capabilities, and overall better patient monitoring because to technological advancements in and around the sector. Many industry professionals are concerned about the potential security risk for medical equipment as cyberattacks become more widespread and complicated. Let’s take […]

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Detailed Guidelines & Standard Operating Procedure (SoPs) for Testing Medical Devices

For the improvement of the medical device sector government is making efforts and updating guidelines from time to time. It is hard for the manufacturer /service provider to maintain all the records of the new updates and work as per the new regulations. To address this situation we provide regulatory services and help our clients

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Drug Device Combination Product

Guideline for CE Drug-Device Combination (DDCs) Product

Drug-device combinations (DDCs) are therapeutic and diagnostic items that mix medical devices, medicines, and/or biological components. Because these are claimed to achieve medication targeting, they are regarded as safer and more effective treatments for local administration and personalized therapy. Such technologies are seen as beneficial to individuals suffering from major health conditions such as cancer,

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borderline products

New MDR Guidance For Borderline Products

Borderline Products: Medical Devices / Medicinal Products As Per MDR New suggestions from the European Commission’s Medical Device Coordination Group provide better definitions for makers determining whether their things are medicines or devices (MDCG). It is straightforward to identify whether a product is a device covered by the Medical Devices Regulation 2017/745 or a drug

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cdsco

Deadline Approaching: CDSCO Issued Guidelines for Medical Devices

CDSCO Licensing Regime for Medical Devices CDSCO (central Drugs Standard Control Organization) is responsible for the approval of and regulation of drugs, IVDs, medical devices, Control over the quality of imported devices, co -ordination of the activities with state drug control organization and providing advice to bring uniformity .As per the rule medical devices are

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CAPA Process

Purpose And Process Of Corrective Action And Preventive Action(CAPA)

CAPA is an acronym for Corrective and Preventive Action. The CAPA process is one of the core cycles in every medical device organization’s quality management system. The FDA requires medical device organizations to break out quality review reports, work activities, returned goods, administration records, concessions, and processes, and investigate the underlying cause of non-conforming devices.

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QMS perspective for Drug device combination

QMS perspective for Drug device combination

To begin with, we will first understand QMS. Quality Management system is a structured process and procedure which covers all aspects of designing, manufacturing, structuring, risk management, product labeling, clinical data, storage and more. This Article explains QMS perspective for drug device combination for a manufacturing company. Combination product regulated by FDA Guidance. Combination product

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