MDDI Medical Device and Diagnostic Industry News Products and Suppliers. While the U.S. regulatory system can be credited with ensuring high standards of patient safety and device effectiveness, the process of submitting a 510(k) can pose many challenges for medical device manufacturers both inside and outside of the United States.
Each 510(k) submission is nuanced and dynamic, with any number of variations, depending on the type of device, the risk level, its history, etc. Therefore, it is essential to have a strong understanding of the most up-to-date 510(k) submission requirements and how they relate to your device. To help medical device manufacturers—especially smaller start-ups and medical device companies outside of the United States (OUS)—to increase the likelihood that their 510(k) submissions will be reviewed and cleared with minimal delays, the following Top 10 Pitfalls should be understood and successfully navigated. 1. Misconceptions about 510(k)’s goals. 2. 3. 4. 5. 6. 7. 8. 9. The second is the “eCopy Program for Medical Device Submissions.”
Putting Guidewires to the Test. Author: Amy Peterson, DDL Addressing sterile single-use intravascular catheter introducers, ISO 11070:1998(E) tests help medical device manufacturers to ensure that products such as guidewires are safe for use.
For guidewires in development, ISO 11070 provides a set of relatively quick and uncomplicated methods with which to evaluate different materials, manufacturing means, and engineering configurations in order to optimize the final product. Below is a crash course in ISO 11070 and tests that manufacturers must know to introduce a safe, effective guidewire to market. The Indium Corporation offers materials for hermetic and cryogenic sealing. Hobby Flyer. Part Drawings - Luer Fittings and Luer Connectors. 30505 92ISO%20594 2%20LUER%20TAPER%20STANDARDS. New Generation of Microlaparoscopic Instruments: Improved Strength, Invisible Scars - SAGES Abstract Archives. Andrew S Kastenmeier, MD, Konstantinos I Makris, MD, Christy M Dunst, MD, Lee L Swanstrom, MD.
The Oregon Clinic Objective: The quest to minimize pain and scarring from surgical access has led to the development of novel techniques and surgical platforms. Natural orifice transluminal endoscopic surgery (NOTES) emerged as a revolutionary method of eliminating external surgical incisions, but it has not achieved widespread acceptance due to inherent technical challenges. Single incision laparoscopic surgery (SILS) has gained popularity by maintaining the laparoscopic approach, while limiting the incisions. Microlap Technologies Rolla, ND. Needlescopy: Ultra-Minimally Invasive Surgery. Minimally invasive techniques like laparoscopy and surgical robotics have dramatically decreased the size of surgical incisions and scars.
But there’s a new type of surgery that goes one step further. Ultra-minimally invasive surgery, also known as needlescopy, uses surgical instruments so small, scars are virtually unnoticeable and pain is minimal. Traditional laparoscopy uses small incisions to access internal anatomy. Bronchoscopic Forceps. The SpineView™ MIS Decompression System - SpineView, Inc. The SpineView™ MIS Decompression System is indicated for use to facilitate access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and is accessorized with surgical instruments for interventional spinal procedures such as discectomy, nucleotomy, and foraminotomy.
The system includes the enVue™ Cannula, and the enCise™ Bone Cutter which create a visualizable working space in the epidural region through a small port of approximately 8mm in diameter. 100% of decompression procedure is under Direct Visualization! Small incision for minimal musculature and soft tissue interruption. The enVue™ clear jaws retracts tissue allowing for greater visualization and bleeding control. The enCise™ osteotome tip can be rotated and precisely positioned against the bone. Surgical Innovations Ltd. Z-XYS. Enjoy!....
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We have two standard formats, available in attractive white aluminum cases for floor, wall, chassis and cart installation. Typical applications include installation of computers, video monitors, surveillance cameras, test and measurement instruments, printers, clinics, doctor’s offices, or whenever safe operation of electronics equipment requires low leakage current levels. This line of enclosed medical transformers offers all the advantages of the toroidal constructions such as low weight, low magnetic strayfield, low mechanical noise, low losses, high efficiency and cool operating temperature.
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In the past decades our expertise as well as the variety of our products have been growing continuously. Apart from standard dimensions we also produce numerous special sizes – even in small quantities. Our modern production technology enables us to realize customer requirements at short notice. The high-precision measuring equipment ensures compliance with tight tolerances. We use a wide range of glass types for the production of our capillaries. The materials we use include the following glass types: The Fiber Optic Association - Fiber Optic Standards. The Fiber Optic Association Tech Topics.
JUNFLON® Peelable Heat-shrink Tube. What is JUNFLON®Peelable Heat-shrink Tube? JUNFLON®Peelable Heat-shrink Tube is the industry’s first peelable heat-shrink tubing, offering time saving and process improvements in Catheter Manufacturing. Problems with traditional method Removing traditional FEP-HST tubing smoothly is a serious problem in Catheter Manufacturing. Large Diameter Fiber Fusion Splicing System LDS II- 3SAE Technologies.
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