medical device regulations Articles
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Medical Device Regulation - Indian Perspective
The Indian Medical Devices industry is mostly import-dependent with no specific regulations in place till recent times. With the introduction of MDR (Medical Device Rules 2017) attempt has been made to harmonize the Indian medical device Industry as per globally prevailed ...
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SmartFreezer®: Meeting the Medical Device Directive for Safe Sample Management
Medical devices are an essential component of healthcare, and they have significantly improved the quality of life for many patients worldwide. These devices may be categorised by their intended use and range from simple non-invasive items to fully implantable devices. The Medical Device Directive 93/42/EEC (MDD) is a regulation that sets out the essential requirements that medical devices must ...
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How Neteera deployed its proprietary AI on BioT’s Distributed Medical Device Platform to Improve Patient Care - Case Study
Medical Tech innovators, Neteera Technology developed their flagship device ‘Neteera 130’ to provide enhanced remote monitoring of patient vital signs, to improve care, and ultimately reduce healthcare costs while enabling optimal comfort for the patients. The Neteera 130 system (marketed as a ‘digital nursing assistant’) provides a continuous, contactless, passive vital ...
By BioT Medical
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A Quick Overview of ISO 13485 Requirements for Medical Device Companies
It is an undeniable fact that safety and quality are the top-most priority for medical device companies. However, the best-practices to maintain these priorities are defined under ISO 13485. You cannot brush aside the need for implementing the right enterprise quality management software to create and maintain the culture of quality and continuous improvements. The software may help you meet ...
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Nanostics Receives CE Mark for its ClarityDX Prostate Test to Detect Clinically Significant Prostate Cancer
Nanostics’ biomarker and machine learning-powered test, ClarityDX Prostate®, received a CE-IVD Mark. A CE-IVD Mark is required for all in vitro diagnostic (IVD) devices to be placed in the European Economic Area, Iceland, Norway, and Liechtenstein and allows Nanostics to market and sell ClarityDX Prostate® in these countries. The ClarityDX Prostate® test provides patients ...
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Familiar but Mysterious: Understanding Software as a Medical Device
As technology continues to advance software has become an important part of most products. It has become integrated widely into medical platforms. In 2019, the Software as a Medical Device (SaMD) market was estimated at about $18.4 million, and it is projected to reach $86 million by 2027 at an annual growth rate of 21.9%. As one of the fastest growing sectors in healthcare, we explore when ...
By BioT Medical
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Newly Released FDA Guidelines for Sepsis Detection & what it Means for Hospitals
Executive Brief On September 28, 2022, the FDA released Clinical Decision Support, Guidance for Industry and Food and Drug Administration Staff. This guidance is long overdue, and with it comes the elimination of any protections for EHRs, or any other vendors, to pretend it’s OK to sell or deploy solutions for patient monitoring and care for life-threatening conditions like sepsis, that ...
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Why Sterile Packaging is Crucial for Medical Devices
Patients who need medical treatment often fear being exposed to harmful germs and unsanitary instruments. Just the thought of a healthcare provider using an unsterilized surgical device or needle is enough to make people feel queasy. As a result, patients find it reassuring to watch a clinician remove healthcare devices from sterile packaging before starting a procedure. Sterile packaging ...
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LegalLookout: EPA Proposes Tighter PM Standards
Untitled Document EPA has been busy addressing particulate matter (PM), a mixture of very fine particles and/or liquid droplets to which exposure is, according to the agency, directly linked to health problems. Proposed NAAQS standard In January, EPA proposed revisions to the primary and secondary national ambient air quality standards (NAAQS) for PM. The proposed ...
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The Importance of Quality Management in the Medical Device Industry
As the world struggles to come up with a treatment for the COVID-19 virus, it’s important to remember all the amazing innovations taking place in the medical device and life sciences world: Implantable devices, like one that measures things like elevated filling pressure and weakened ventricular contraction, enabling physicians to detect risk of heart failure weeks in ...
By EtQ, LLC
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