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Iso 13485 Articles & Analysis
17 articles found
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 ...
At first glance, a cheaper drainage bag may seem like a smart move for a tight budget. But procurement teams know the real cost of a product goes far beyond the price on the invoice. When medical drainage bags fail to perform, the ripple effects show up in the form of surgical delays, patient dissatisfaction, and even infection risk. Discover the hidden costs of low-quality drainage ...
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 ...
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 ...
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 ...
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 ...
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. ...
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 ...
Developing and manufacturing molecular diagnostics platforms and test kits for detecting human pathogens. Specializing in Antimicrobial Resistance Management and Hospital Associated Infections (HAIs), by reliable, cost-effective molecular diagnostic solutions for detecting Gastrointestinal Infections including most clinically relevant bacteria, parasites, viruses and antibiotic resistances. ...
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 ...
ByAKCP
The medical device industry is worth hundreds of billions of dollars, but companies who take their eye off the ongoing need for quality management could find themselves under an unwelcome federal compliance spotlight. According to a recent U.S. Food and Drug Administration (FDA) Medical Device Enforcement and Quality Report, the agency has increased annual inspections at manufacturing facilities ...
ByEtQ, LLC
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 ...
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 ...
Safety is absolutely paramount in the medical industry, with lives literally at stake if something were o go wrong. Regrettably, this was more than reinforced recently following the tragic news of a death of a newborn at a hospital in Sydney, Australia, after it was mistakenly administered nitrous oxide (N2O) instead of oxygen (O2) in July this year. A tragic occurrence of similar circumstance ...
Safety is absolutely paramount in the medical industry, with lives literally at stake if something were to go wrong. Regrettably, this was more than reinforced recently following the tragic news of a death of a newborn at a hospital in Sydney, Australia, after it was mistakenly administered nitrous oxide (N2O) instead of oxygen (O2) in July this year. A tragic occurrence of similar ...
The expanding Internet means more: more data, more collaboration, and more complex systems of interactions. You can find hundreds of both expensive and free templates for ISO 13485, offered by various consultants, companies and experts. But even if the ISO compliance is guaranteed on some sites, still it is not so certain that you will get what is promised. These sites are basically presenting ...