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Cybersecurity in Connected Medical Devices in Modern Health

Cybersecurity in Connected Medical Devices: Compliance and Risk Mitigation

All Category, Blogs, Medical Device, regulatory /

The integration of connected medical devices into healthcare systems has revolutionized patient care, enabling real-time monitoring and data-driven decision-making. However, this interconnectedness also introduces significant cybersecurity risks that can compromise patient safety, data privacy, and the integrity of healthcare operations. As cyber threats evolve, it is imperative for manufacturers, healthcare providers, and regulators to adopt […]

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Point-of-Care Diagnostics in Healthcare

Point of Care Diagnostics Making Healthcare More Accessible 

All Category, Blogs, Clinical Regulatory, Medical Device, regulatory /

Point-of-care diagnostics (POC) represent one of the fastest-growing segments in the global in-vitro diagnostics (IVD) industry, enabling rapid medical testing at or near the site of patient care. This capability significantly reduces diagnostic turnaround times, facilitates immediate clinical decision-making, and improves patient outcomes, especially in resource-limited or time-critical scenarios. The convergence of advanced biosensor technologies,

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PV Requirements for medical devices and combination products

Global Pharmacovigilance Requirements for Devices and Combination Products

All Category, Blogs, Medical Device, Pharmacovigilance /

The traditional boundaries separating pharmaceuticals, biologics, and medical devices have blurred. With the rise of combination products, from drug-eluting stents and prefilled autoinjectors to inhalers with embedded sensors, the regulatory landscape has undergone a seismic shift. While pharmacovigilance (PV) for pharmaceuticals is well-established, the safety monitoring of PV for devices and combination products introduces distinct technical and

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Regulatory oversight of companion apps

Regulatory Oversight of Companion Apps: Where Do They Stand? 

All Category, Blogs, Medical Device, regulatory /

Imagine sipping your morning coffee while an app effortlessly syncs with your glucose monitor. These are companion apps, digital tools that extend the functionality of medical devices. But with innovation comes responsibility. So, who ensures these apps are safe, effective, and secure?  Companion apps, particularly in healthcare, are rising fast. But the regulatory frameworks that

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All About Software as a Medical Device (SaMD)

Understanding Software as a Medical Device (SaMD)

All Category, Blogs, Medical Device /

What is Software as a Medical Device? The International Medical Device Regulators Forum (IMDRF) defined Software as a Medical Device (SaMD) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. The FDA also aligns with this, noting SaMD runs on

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Medical Device Regulations in the United States

Medical Device Regulations in the United States

All Category, Blogs, Medical Device /

Medical devices are indispensable tools that help improve the ability to diagnose and treat illnesses, both simple and complex in nature. As technological disruptors become increasingly available in the healthcare industry, medical device manufacturers are developing more advanced devices which necessitates a robust regulatory framework. Among the regulatory agencies, the United States Food and Drug

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A Guide to Using FDA’s eSTAR for Medical Device Submissions

All Category, Blogs, Medical Device /

The United States Food and Drug Administration (USFDA) introduced the electronic Submission Template and Resource (eSTAR) program as part of its efforts to modernize and streamline medical device submission. This initiative aims to streamline the 510(k)-submission pathway, which is essential for manufacturers seeking to bring new medical devices. As of Oct 1, 2023, the use

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EU Classification of AI medical devices and IVDs

Navigating EU Classification Standards for AI in Medical Devices and Diagnostics

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The European Union (EU) has introduced stringent classification standards for Artificial Intelligence (AI) applications in medical devices and in vitro diagnostics (IVDs) to ensure patient safety, product efficacy, and compliance with regulatory frameworks. With AI technologies, these standards are crucial in defining the pathway for their integration into healthcare systems. This blog dives into the

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Total Product Life Cycle Advisory Program in Medical Devices

Enhancing Medical Device Innovation with the Total Product Life Cycle Advisory Program

All Category, Blogs, Medical Device /

The medical device industry is driven by constant technological advancements and the need to meet growing patient demands. Ensuring that these innovations are safe, effective, and reach the market promptly is a critical aspect of public health. To address this need, the FDA has implemented the Total Product Life Cycle (TPLC) Advisory Program (TAP), a

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Regulatory Framework for Software and Artificial Intelligence as Medical Device

All Category, Blogs, Medical Device /

The convergence of healthcare with technology has led to giant innovations, one of the most significant being the use of software and artificial intelligence (AI) as medical devices. Such developments have been called Software as a Medical Device (SaMD) by many and have wide applicability in transforming the diagnosis, treatment, and care of patients medically.

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