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 […]
3 Clinical Trends Shaping the Medical Device Space in 2019
By Mike Rigert, Staff Writer, MasterControl Perhaps no other sector of the life sciences is experiencing as much growth, transformation and opportunity as the medical device industry. Globally, the medtech arena is expected to grow every year by more than 5 percent, with annual sales worldwide reaching $800 billion by 2030, according to KPMG.(1) In […]
Understanding the MDR & IVDR: What Medical Device Companies Need to Know
By Brandy Chittester, MS, CCRA, President These regulations are intended to place a greater emphasis on safety, with greater requirements for clinical evidence and increased oversight by regulatory agencies. The regulations will not allow grandfathering of previously approved products, so device manufacturers will need to re-evaluate their entire product portfolio to identify the steps needed […]
From 8 Weeks to a Few Days: How Vaupell helped K2M increase speed to market on their life-saving medical prototypes
The Company K2M, now a part of Stryker, is a medical device innovator and manufacturer that works closely with surgeons to design spinal implants and surgical instrumentation. Industry: Spinal medical devices Location: Headquartered in Virginia, with offices in the UK and Germany Company Size: 500 Employees The Project Critical Business Issues: K2M’s prototyping process was […]
The Future of Laser Micro Manufacturing in Medical Device Markets
Introduction Laser Micro Manufacturing Technologies and its Impact on Medical Device Manufacturing Laser micro manufacturing is a compilation of technologies developed to address an ever increasing demand for micro-scale manufacturing in the Medical Device and Advanced Diagnostics Markets. These technologies include laser ablation, laser cutting, laser drilling, and laser welding. Each technology addresses a common […]
The Critical Importance of an Effective Data Strategy for EU MDR
The deadline for the new European Medical Device Regulation (EU MDR) is just around the corner. Are you ready? By now, your organization has probably conducted a portfolio review and assessment. You might have even progressed to your Clinical Evaluation Report. But during the assessment process, you may have discovered significant data gaps. You might […]
Next Generation LSR Technology for Medical Injection Molding
Manufacturers across industries from automotive, consumer goods, and healthcare, use a liquid injection molding (LIM) process to create silicone rubber parts that are durable and easy-to-mold. The current LIM process utilizes a two-part liquid silicone rubber system. Typically, the Part A base polymer contains a catalyst to begin the crosslinking process. The Part B polymer […]
Quick Launch Program for Micro Medical Production
By Lindsay Mann, Director of Sales & Marketing For OEMs who need a rapid prototype of their new medical device design, there are plenty of vendors to choose from. But for OEMs who are ready to move into production or need to miniaturize a next-generation product already on the market, it can be much more […]
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