The MDR Technical Documentation File Builder is the latest tool added to RAMS – Regulatory Affairs Management Suite, our software-as-a-service platform for digital regulatory solutions. This feature offers step-by-step guidance on building documentation to EU MDR specifications. The MDR Technical Documentation File Builder: Guides users through creation of a Technical Documentation File References eQMS to seamlessly […]
Optics makes amazing things possible in biological research and medicine—and Optikos makes it happen
We partner with clients in life sciences and medical technology hubs around the world who are developing medical devices and diagnostic tools enabled by optics. By Optikos Corporation Whether you’re a start-up in the early concept stage, or a Fortune 500 looking to revamp a mature product, Optikos can help make your next medical device […]
3 Tech Trends That Will Accelerate Manufacturers’ Time to Market
By 2025 the global medical device manufacturing market is expected to exceed $600 billion, driven largely by the aging population, increasing prevalence of chronic diseases, technological development and demand for more personalized treatments.1 Regulatory bodies are also reacting, both to protect consumer safety and to remove unnecessary roadblocks for device companies. Despite the optimistic outlook for manufacturers, however, […]
Putting the Best Foot Forward in Healthcare
By Maurizio Lauria, Brand Manager, STEUTE Meditech Inc. Medical professionals now require more sophisticated technology, greater efficiency and a much greater degree of specialization in the medical devices they use. Changes have been especially swift in operating rooms, with new suites, minimally invasive techniques and better support for outpatient surgery. It’s within the realm of […]
Materion Precision Coatings Products and the Fight Against the COVID-19 Pandemic
By Rich Koba, Senior Product Manager Materion Precision Coatings offers UV, visible and infrared filters that are being used in the fight against the COVID-19 pandemic. These filters are being used in three general applications: (1) LWIR filters used to manufacture thermal cameras and temperature sensors to measure a person’s temperature and check for fever. […]
Enhanced Catheter Performance Made Possible with Laser Cut Tubing
Intro: Resonetics PRIME Laser Cut™ offers medical device designers a new and fresh option for developing the latest life saving catheters and delivery systems. Laser cut tubing (LCT) has been used in medical device manufacturing for over 30 years with major advancements following the push for miniaturization for minimally invasive procedures. Laser cutting uses a […]
Coronavirus & Barrier Material Tests
Respirators And Barrier Materials By Sarah Smit, Senior Lab Operations Manager and Janelle Bentz, Study Director III Coronavirus The new strain of coronavirus originating in Wuhan, Hubei Province, China has raised new concerns. This virus is similar to the SARS coronavirus and can cause mild to severe respiratory illness. The virus spreads through droplet transmission. […]
Emergo by UL launches 510(k) Builder for streamlined US FDA medical device submissions
Emergo by UL, a global medical device and healthcare technology consultancy, has rolled out 510(k) Builder, a new subscription-based software tool to simplify and streamline medical device manufacturers’ FDA 510(k) submissions in order to obtain faster US market access. Available through Emergo by UL’s Regulatory Affairs Management Suite (RAMS) automated medical device registration and compliance […]
How Digitization Can Help Life Sciences Manufacturers Amplify Lean Principles
By Dave Edwards, Executive Vice President, MasterControl Life sciences manufacturing in 2019 is a dynamic, immensely competitive space in which new markets, ever-changing regulations and exponentially evolving technologies require the C-suite to look for ways to reduce overhead and create greater efficiencies on the shop floor. This imperative means looking for opportunities to improve levels […]
Lean Product Launch: 3 Ways 3P Events can Boost Efficiency and Speed to Market
By Todd Clark, Program Manager, Viant Get a diverse group of smart people in a room and present them with a challenge. Add brainstorming and collaboration. At the end of the day, the best ideas rise to the top and breakthrough concepts emerge. That’s the magic of a Lean Production Preparation Process (3P) event. For […]
Is your user experience as good as your technology?
By Jesse Darley, Director of Mechanical Engineering & Principal, Delve No doubt, you are passionate about the impact medical devices have on the lives of the patients that need them. In many cases, devices save lives. In more cases, they extend or improve lives. At the core of most devices is a technology that solves […]
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