Medical Device Regulations Articles
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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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How Proper Packaging Improves the Shelf Life of Medical Devices
Medical devices are incredibly important in today’s world. They play a significant role in the treatment and prevention of various medical conditions. However, their effectiveness can be compromised if they are not packaged correctly. Packaging is an essential component of maintaining the integrity and shelf life of medical devices, especially during transportation and storage. Read on ...
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Healthcare Packaging Validation: Assuring Patient Safety
Sterile medical packaging plays a vital role in protecting patients from harmful bacteria and viruses. However, many processes can damage the integrity of sterile packaging as products move through the supply chain. Improper sterilization techniques, mishandling during shipping, and other mishaps can degrade packaging and cause loss of sterility. Regulatory agencies require all sterile packaging ...
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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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Ultra Low Temperature (ULT) Pharmaceutical Freezers
What is an Ultra Low Temperature Freezer? An ultra-low temperature freezer (ULT freezer) typically has a temperature range of -45°C to -86°C and is used for the storage of drugs, enzymes, chemicals, bacteria and other samples. They are available in various designs and sizes depending on how much storage is needed. An upright ULT freezer gives easy access for frequent use and a chest ULT ...
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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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What is Sepsis? Key Symptoms, Potential Complications, and Vital Treatment
The term sepsis describes the body's extreme response to infection. When a person suffers from sepsis, his or her immune system has been triggered in response to an infection, which causes inflammation and damages tissues in the body. Symptoms of Sepsis The symptoms of sepsis may include: Fever (102 degrees Fahrenheit or higher) Chills Rapid breathing (above 20 breaths per minute) or ...
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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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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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4 factors that make a nasal aspirator safe
Do you remember the moment when you found that you have to clear your baby’s nose? You probably thought it was a joke and you didn’t want to believe it. “A nasal aspirator? What else will they come up with… Do I really need it? Is that even safe?!” Most parents share your doubts at first. However, these uncertainties disappear once you find out how much relief a ...
By Nosiboo
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What is an IVD Medical Device? Mic Provides a Compact Option
The global COVID-19 pandemic has spurred on a new demand for diagnostic equipment and products in the race to minimise spread. Airports, workplaces, border checkpoints, hospitals and countless other facilities - they’ve all needed accurate qPCR testing capabilities. ...
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Oxygen for Patient Care and Manufacture of Covid-19 Vaccines
In the Focus: Inmatec Gasetechnologie Gmbh & Co.Kg Medical oxygen plays an important role in coping with the corona crisis. It is used worldwide to treat Covid patients and is now also used to manufacture life-saving vaccines. With self-sufficient O2 generation, hospitals and pharmaceutical manufacturers secure the supply and reduce their costs at the same time. Medical oxygen has been used ...
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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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Medical-Grade Refrigeration for Storage and Transport
All You Need To Know About Medical-Grade Refrigeration Units For Pharmaceutical Storage And Transport One of the pillars for a successful healthcare system is the stable maintenance of vaccines, medications, reagents, and patient samples. These tend to be time- and temperature-sensitive. Vaccines and medicines are transferred through a cold chain from creation up to the time it is administered ...
By AKCP
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EDAP Announces Exclusive Worldwide Distribution Rights to Exact Imaging’s Micro-Ultrasound Technologies
Exact Imaging is a leading developer of ultra-high-resolution micro-ultrasound diagnostic technologies Micro-ultrasound ExactVu™ is the only ultrasound-based imaging tool with published data demonstrating prostate cancer diagnostic capabilities similar to MRI Combination of Exact Imaging’s micro-ultrasound and EDAP’s Focal One® represents the most complete offering for ...
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Yaguo launches an Innovative Medical Device
At the beginning of Chinese New Year, Beijing Yaguo Technology Co., Ltd.'s innovative medical device "Respiratory Power" respiratory neuromuscular stimulator was officially launched. "Respiratory power" has been established in 2015 as a core innovative product of Yaguo, Through 4 years of continuously efforts, after research, demonstration, design, development, and clinical registration it has ...
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The Hex Drill helps increase operational efficiency at leading US Trauma Center - Case Study
Arbutus Medical has developed and patented a radically affordable orthopedic drilling kit to combat rising healthcare costs and improve access to safe surgical power tools around the world. In September 2019, the kit was implemented at a leading trauma center in the United States for use in damage control ...
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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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Why you need an ISO certified design house and Contract Manufacturer
Working with a development firm with a certified quality system saves time and reduces cost. A company’s quality system defines the development, manufacturing, and product lifecycle management procedures that are critical to establishing effective internal processes. ISO-13485 is the primary quality system used in the medical industry. Many design firms claim that by not becoming ISO ...
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