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Tag: SaMD
13Jul 2024
FDA, EU, EU MDR, Regulations, USA Cubicdesignz Comments: 0

Software As a Medical Device and Its Clinical Evaluation

As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of Software related to medical devices. The other two types of medical device software include Software that is an integral part of the medical device (medical device software) and Software used in manufacturing or maintaining the medical device. Software...
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05Feb 2024
EU, Regulations, Swiss, UK Cubicdesignz Comments: 0

SaMD Devices Classification

SaMD is software intended for one or more medical purposes that perform these without being part of a hardware medical device. Medical device software is meant to be used, alone or in combination, for a purpose specified in the definition of a “medical device” in the MDR or IVDR, regardless of whether the software is independent or driving or influencing the use of a device. You can read more on the SaMD Regulation here. To be qualified as medical device software, the product must first...
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05Feb 2024
EU, Regulations Cubicdesignz Comments: 0

Cybersecurity for medical devices in Europe

EU Cybersecurity laws for Medical devices are advancing, and the use of software medical devices is also increasing daily. The increased interconnection of medical devices to computer networks and technological convergence have made devices and software programmes vulnerable to mishaps. The importance of protecting patient data from cyber-attacks is now well recognised. With the advancement of software as a medical device, proper regulations must be established to ensure the safety and security...
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05Feb 2024
EU, EU MDR, FDA, Regulations, USA Cubicdesignz Comments: 0

Software As a Medical Device and Its Clinical Evaluation

As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of Software related to medical devices. The other two types of medical device software include Software that is an integral part of the medical device (medical device software) and Software used in manufacturing or maintaining the medical device. Software...
Read More
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