Category: Medical devices

Medical Device Software Under EU Regulations: Supporting Safer and Smarter Healthcare As healthcare continues to embrace digital transformation, Medical Device Software (MDSW) has become a critical component in improving patient outcomes, streamlining clinical workflows, and enhancing decision-making.

What is Medical Device Reporting (MDR)? Medical devices are vital to modern healthcare, helping diagnose, monitor, and treat a wide range of medical conditions. However, ensuring these devices remain safe and effective after they enter the market is equally important.

What is Software as a Medical Device (SaMD)? In the ever-changing healthcare environment, it is crucial for organizations that seek innovation in the healthcare sector to understand what Software as a Medical Device (SaMD) is. Software as a Medical Device (SaMD) is a term used to describe software that is designed to carry out medical… Continue reading What is Software as a Medical Device (SaMD)?

What is UDI (Unique Device Identification)? In the modern healthcare system, ensuring the safety and traceability of medical devices is extremely important. Unique Device Identification (UDI) is a global regulatory system designed to assign a unique code to every medical device. This system helps manufacturers, regulators, and healthcare providers easily identify and track devices throughout… Continue reading What is UDI (Unique Device Identification)?

What Is EU MDR? The EU MDR Medical device regulation that came into effect in 2021 reformed the process of medical device and drug-device combination products regulation in the EU. In the case of the pharmaceutical industry, it provides more rigorous questioning, more demanding clinical evidence, and more intensive quality control of each of the… Continue reading What Is EU MDR?

Statement of Policy Intent: International Recognition of Medical Devices The UK Medicines and Healthcare products Regulatory Agency (MHRA) aims to facilitate quicker and more efficient access to medical devices by leveraging the expertise and decision-making processes of international regulatory partners. This initiative will benefit patients by allowing the MHRA to recognize approvals from other regulatory… Continue reading International Recognition of Medical Devices | MHRA