Harmonized standards need to be reviewed and revised to reflect requirement changes under the MDR and IVDR. The creation of Common Specifications, as well as changes to ISO 14971, further complicate the transition for med device manufacturers.
One topic that often generates confusion — and sometimes heated debate — is whether study participants should be trained on a product’s use prior to testing. Trained participants may be more likely to use the product as intended during testing but, as testing is intended to simulate real-life product use, training may not always be appropriate.
Auditing programs perhaps implicitly provide feedback at the reporting stage of an audit. Most companies and third-party auditing programs conduct a technical review of completed audit reports.
Continuously learning systems (CLS) are artificial intelligence (AI) algorithms that constantly and automatically update themselves as they recognize patterns and behaviors from real-world data — enabling companies to become predictive, rather than reactive, with quality assurance.
Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs.
As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.
Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. KMC's executive director of engineering, Scott Leon, weighs in on the subject.
The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.
Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production.
maxon motors offers an outstanding line of DC motors featuring no magnetic cogging, low electromagnetic interference, low inductance, high efficiency, and high acceleration due to low mass inertia. These motors offer linearity between voltage and speed, load and speed, and load and current. The motors’ small, compact designs allow them to bear high overloads for short periods of time, and deliver small torque ripple via multi-segment communicator.
FLIR offers the FLIR A8200sc and FLIR A8300sc high-sensitivity MWIR cameras designed to produce low-noise HD thermal images for electronics inspection, aerial thermal mapping, non-destructive material testing, and industrial R&D applications. The A8200sc produces crisp, 1.0 megapixel (1024 x 1024) thermal images, while the FLIR A8300sc produces 921,600 pixel (1280 x 720) images, both with very low noise to capture the finest image details.
Run efficient inspections on the web with our web-based deployment of all our quality inspection applications.
Cardinal Health offers the RePly Uni-Patch™ R Series of stimulating electrodes designed for durability, flexibility, and comfort in a variety of treatments. Made with a long-lasting 0.025-inch thick hydrogel for reliable adhesion over body contours, this electrode provides firm yet gentle electrode-to-skin contact for multiple applications.
Assembly, packaging and sterilization for critical medical devices are vital processes that Donatelle performs with unparalleled rigor and skill. Options are available to choose from white room, ISO 7 (class 10,000) or ISO 8 (class 100,000) cleanroom assembly and packaging, in Donatelle’s vertically integrated facility.
KMC Systems offers decades of experience in solving complex medical engineering and design challenges, and in considering innovative, highly-automated solutions for the development of full-system instrumentation. KMC Systems engineers work collaboratively with customers to achieve optimal interdisciplinary solutions to laboratory automation challenges, Design for Manufacturability and Serviceability (DFM and DFS) challenges, and medical device verification and validation.
Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, health systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide.
The company provides clinically-proven medical products and pharmaceuticals and cost-effective solutions that enhance supply chain efficiency from hospital to home. Cardinal Health connects patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management.
Passion for technology has driven SMC Ltd. to be a leading manufacturing partner to top medical OEM’s in the diagnostics, pharmaceutical and medical device markets. Services include program management, product launch/scale-up, product design, engineering, prototyping, strategic supply chain management, custom thermoplastics component manufacturing, assembly, reagent filling, pouching, pre-packaged drug handling, automation, testing, and packaging.