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Safety Pen Needles Instruction Articles & Analysis
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In today’s highly regulated industrial landscape, ensuring SIL2 compliance in additive manufacturing and pharmaceutical production is critical. These sectors rely on accurate, safe, and compliant equipment to maintain operations and protect both employees and end-users. One standard that has emerged as a benchmark in safety-critical processes is SIL2 compliance. This article explores what ...
Quality issues in medical devices often point to underlying weaknesses in the system, and ISO 13485-compliant CAPA is essential for correctly identifying cause and preventing the problem from recurring. Here’s an overview of CAPA requirements in ISO 13485 for medical device ...
Choosing the wrong supplier for medical drainage bags can expose your facility to safety risks, compliance violations, and costly downtime. Procurement professionals are expected to evaluate products quickly and confidently, but not all warning signs are obvious upfront. This guide breaks down five key red flags to watch for so you can make smarter, safer purchasing decisions and ...
Leading medical staff in the UK, writing for medical journal ‘Thorax’, are calling for industries and governing bodies to follow Australia’s new legislation and ban the use of engineered stone, commonly used for kitchen worktops. It comes after cases of silicosis linked to engineered stone exposure recently came to light globally. Workers who have been exposed to engineered ...
Doctors and nurses have long relied on tried-and-true medical technologies to care for their patients, but the ever-increasing focus on patient safety has made innovation in this field a priority. One growing technology is the use of marker bands, which are platform agnostic data capture tools (e.g., barcodes or RFID) used to monitor patient conditions accurately and efficiently. Through its ...
Antibody-Drug Conjugates (ADCs) represent a groundbreaking advancement in targeted cancer therapy, combining the specificity of antibodies with the potency of cytotoxic drugs. The development and production of ADCs are complex processes that require a deep understanding of both biology and chemistry, alongside cutting-edge technology. This article delves into the intricacies of ADC development ...
Whether you're running a small business, managing a healthcare facility, or just looking to enhance your cleaning routine, buying the right wet wipes machine can make all the difference. But with so many options out there, how do you know which one is best for your needs? Don’t worry – we've got you covered. In this article, we'll break down 5 essential tips to help you purchase the ...
Do you ever feel like the medical devices we rely on to help cure and prevent illnesses are not getting enough respect or attention? While most of us never take a second glance at them, they perform an incredibly vital role in improving our overall health. A closer look reveals that these small instruments have even more complexity than meets the eye. Showcasing one such instrument, today’s ...
Doctors and nurses have long relied on tried-and-true medical technologies to care for their patients, but the ever-increasing focus on patient safety has made innovation in this field a priority. One growing technology is the use of marker bands, which are platform agnostic data capture tools (e.g., barcodes or RFID) used to monitor patient conditions accurately and efficiently. Through its ...
Introduction The pharmaceutical industry faces stringent regulatory requirements to ensure the safety, efficacy, and quality of drug products. Among these, Current Good Manufacturing Practice (CGMP) guidelines set by agencies such as the U.S. Food and Drug Administration (FDA) play a pivotal role. Pharmaceutical CGMP manufacturing encompasses all processes that abide by these guidelines to ensure ...
Like any healthcare investment, consideration needs to be given when deciding which fractional exhaled nitric oxide (FeNO) device might best suit the clinical area in which it will be used. So, what would be sensible to consider when including FeNO devices for implementation into the respiratory pathway? And how does the NObreath® measure up? External approval is an important factor in ...
Medical Equipment Relocation Welcome to Armstrong Scientific, your trusted partner in seamless and reliable medical equipment moving. With years of experience and a proven track record, we take pride in providing top-notch medical equipment relocation services to healthcare facilities, research centers, and medical institutions across the country. Our dedicated team of professionals is committed ...
It is important for employers to know the wind chill temperature so that they can gauge workers’ exposure risk better and plan how to safely do the work. It is also important to monitor workers’ physical condition during tasks, especially new workers who may not be used to working in the cold, or workers returning after spending some time away from work. The National Oceanic and ...
Host Cell Residual DNA (rcDNA) refers to fragments of DNA derived from host cells that may be present in biological products. These products must not contain foreign substances, particularly host DNA, to avoid immune rejection and potential threats to life safety. Regulatory agencies worldwide have imposed strict limits on the amount of rcDNA, and various pharmacopoeias have outlined several ...
Mental health is a critical concern for all companies. One in five individuals will experience a mental health problem during their lives, according to the World Health Organization. For many people, the workplace is where mental health problems first begin and/or become exacerbated. ...
Medical History Jane is a 40-year-old, married mother of two teenage boys. She teaches at the local elementary school and has been in good health for most of her life. She has no surgical history. Her most severe ailment up to this point has been the flu at age 27. Her students are first-graders; they are often difficult to control. She also experiences the normal stresses of raising ...
Futura Medical has announced positive results from a clinical trial looking into MED3000, a topical gel formulation for the treatment of erectile dysfunction (ED). The results, from the confirmatory phase 3 clinical study, FM71, were announced today (August 31). MED3000 is a breakthrough, fast-acting gel produced by Futura Medical’s transdermal DermaSys drug delivery technology. It is ...
Medical device companies creating technical documentation, clinical / post-marketing reports, labeling and quality documentation with increasing regulations and recent MDR/IVDR compliance in mind may find that their traditional approaches to these types of content may no longer work. The old document-based approach of creating plans/reports continuously and technical documentation does not lend ...
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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 ...
The purpose of formulation development is to ensure that the drug is safe, effective, stable, and convenient to use. If the dosage form is improperly selected and if the prescription and process design are unreasonable, it will have a certain impact on the quality of the drug product, and even affect the drug’s efficacy and safety. Therefore, formulation research occupies a very important ...