Updating Your QMS For UDI | Ultrasensitive Peanut Allergy Test Developed

Guest Column Updating Your Quality Management System (QMS) For UDI   By Dan O'Leary, president, Ombu Enterprises The preamble to the FDA's Quality System Regulation states, "FDA also notes that the quality system regulation is premised on the theory that adequate written procedures, which are implemented appropriately, will likely ensure the safety and effectiveness of the device." While specific to Part 820, this principle carries throughout all the parts of the regulations. In each case, you need to identify your implementing procedures and update them for unique device identification (UDI). Featured Article The Challenges Of Manufacturing Combination Components By ProMed Molded Products Inc. Differences in regulatory requirements between medical devices and pharmaceutical products present unique challenges to companies manufacturing combination products. This white paper discusses some of challenges ProMed faced in its journey to begin manufacturing drug/device components, along with some of the solutions it successfully implemented along the way. Resources Six Trends In Robotics In The Life Sciences Changes in government regulations and market conditions are forcing life science OEMs to build their products using faster, smaller, and more modular technologies. This article outlines the six major industry trends that have arisen from this turbulent development environment. Managing Risk In Medical Connectors Regardless of their end use, electrical connectors must undergo a risk assessment profile in order to stay compliant with applicable standards. This paper will help educate designers and manufacturers of medical devices on some recent changes made by the FDA and the implications of the new regulations. Endoscopic Hemostasis Clip Device Case Study A medical device manufacturer was struggling internally to develop a hemostasis clip device that would allow for an expansion of its endosurgery strategy. The company engaged MedVenture and raised design issues about its technology that it feared would be impossible to overcome. Miniature Optical Encoders For Medical Positioning Devices Canon’s SR series of miniature optical encoders has been designed to fit into motion control devices that require the utmost accuracy and stability with limited space, such as robotic arms for surgery, nanopositioning stages, microscopes, and other medical devices. Most Popular News • New Ultrasensitive Test Developed To Detect Peanut Allergies • Researchers Optically Stimulate The Brain To Control Pain • Nikon Moves Into Medtech With $400M Acquisition Of Optos • Pregnancy Test + Nanotechnology = Fast, Cheap Kidney Failure Test • Boston Scientific Gains FDA Clearance For New SpyGlass System • Paper-Based Test Diagnoses Ebola, Other Fevers In 10 Minutes • Could 3D-Printed Guides Enable Personalized Nerve Regeneration Therapy? • Scientists Developing Bionic Hand That Provides Realistic Tactile Sensations Featured Products And Services Medical RF And Microwave Semiconductors Skyworks offers a large variety of RF and microwave semiconductor products for use in medical devices. Common applications include glucose monitoring, defibrillators, hearing aids, pacemakers, MRI scanners, and others. • Request Information Skyworks Solutions, Inc. Low-Foaming, Ion-Free Detergent Detergent 8 is concentrated to save you money, biodegradable, and readily disposable. Its penetrating wetting power saves you time. It’s free rinsing to give you reliable results and no interfering residues. Download Datasheet • Request Information Alconox, Inc. Cleanroom Injection Molding For Disposable Medical Devices Phase 2 Medical’s Rochester, NH, location was recently outfitted with 2,500 sq. ft. ISO Class 8 (100,000) cleanroom facility with an injection molding press. This was done in an effort to integrate quality plastic components in their customers’ disposable medical devices. • Request Information Phase 2 Medical Manufacturing, Inc. Sensors For Low-Pressure Measurement In Medical Devices First Sensor's Sensortechnics LDE series of ultra-low pressure sensors offer pressure ranges from 25 Pa (0.1 in H2O); full scale, very high offset stability and accuracy; simultaneous digital SPI bus and analog output; and high immunity against dust contamination and humidity. Download Datasheet • Request Information First Sensor AG