An early-stage medical device company required a prototype of a unique instrument procedure case that involved unique seals and hinges that would experience high mechanical forces.
US FDA guidelines for storing and protecting electronic records—known as 21 CFR Part 11—have been in place for more than 20 years. However, due to advancements in technology and innovation, combined with the sheer volume of data being generated, the regulation has never been as relevant as it is today for
A short white paper describing the use of the mass flow method of leak detection for finding small leaks in large volumes.
Temperature affects are a significant consideration when testing for leaks when using pressure or flow measurement techniques. These are two sources of temperature effects; adiabatic, the effect of changing the pressure of the test medium, and ambient, the effect on the test piece by the environment. This
Inhalers are among the most commonly used devices for treating respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). With each inhalation through the inhaler, the device delivers a specific amount of medication to the lungs. However, when it comes to proper inhaler use, misuse
Orchid Orthopedic Solutions focuses on both bone on-growth coatings and bone in-growth coatings with expertise in sintered coatings, spherical, asymmetric and porous foam used in on-growth coatings. In-growth coatings are usually done with plasma spray, using titanium hydroxyapatite, or titanium on PEEK (poly
Medical procedures and therapies are often faced by the same challenge: accurately measuring and controlling lowest flow rates down to the microliter per hour range. In most of these cases the outcome of the therapy, as well as the well-being or even the survival of the patient strongly rely on the reliable a
Proximal flow sensors are widely used in respiratory devices for intubated patients and non-invasive ventilation patients in hospitals, home care situations and emergency rooms. With applications ranging from neonatal to adult care, the associated requirements for proximal flow sensors are both diverse and ch
Measuring gas flow in applications requiring high precision and cost-efficiency is a challenge. Experience in
recent years has shown that microthermal flow sensors are superior to other technologies.
The Henia1000™ has been designed to fill a gap in the market by producing a porous coating outside of the capabilities of a sintered coating. The Henia1000™ Titanium vacuum plasma spray (VPS) process can be applied to Ti6Al4V, CoCr and Zr-alloy substrates, which combines the biocompatibility of titanium with
Porous titanium coatings onto polymers are of great interest to medical industries. A vacuum plasma spray (VPS) process has been developed to coat PEEK with a micro porous biomimetic titanium coating. This study reports the experimental characterization of the topography and microstructure and of the mechanic
Orchid Orthopedic Solutions has developed a form of 17-4ph stainless steel which, following initial testing, increases the impact strength by up to 5 times and vastly improves its corrosion resistance, whilst maintaining all other properties, such as tensile strength and hardness. This is anticipated to make
NSK's MBSA Series combines a precision ground ball screw with an NEMA stepping motor. This innovative design delivers a compact, space-saving design eliminating the need for motor couplings providing maximum precision for laboratory equipment and medical devices.
Sensor technology takes infusion pumps to the next level by making failure detection reliable, even for infiltration.
The worldwide swine flu epidemic of 2009/2010, Ebola in Africa in 2014, the MERS outbreak in South Korea in
2015 - the list could be extended at will and makes one thing clear: that viruses and other pathogens can spread
worldwide in no time. Hospital patients trust that they will receive the best poss
ePTFE, a non-woven, open pore Fluoropolymer plastic, is suitable for the critical demands of medical applications and other industries.
The "sticking" or adsorption of proteins and other bio-substances onto the surfaces of diagnostic instrument components and devices is a major challenge for manufacturers in the medical industry. When these substances remain on metal surfaces, the accuracy of results and longetivity of the system is compromis
Proteins and other biomedia are prone to adsorbing onto or corroding stainless steel surfaces, leading to inaccuracies in clinical assays and detrimental downtime of the analytical instrument.
Medical-grade textiles have been proven to deliver the high degree of versatility and performance that OEMs need to create implantable devices that best meet the needs of today's surgeons – and patients. As a result, the market for medical textiles is rapidly growing.
The FDA defines shelf life as the term or period during which a device remains suitable for its intended use. Fitness for use can be impacted by both maintaining sterility of the package and the performance characteristics of the device.