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 […]
I’m a medtech expert who survived a tumor in my head
More than five months into a successful recovery from surgery to remove a golfball-sized meningioma, medtech industry veteran Bill Betten reflects on lessons learned. Bill Betten, Betten Systems Solutions A neurosurgeon walks into the room and says, “So you’re the interesting case.” Not exactly words one wants to hear, but the scientist and engineer inside […]
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 […]
MHRA clarifies U.K. REP role in post-Brexit medical device market
By Ronald Boumans, Emergo Group The Medicines and Healthcare products Regulatory Agency (MHRA), Great Britain’s medical device market regulator, has published new details on the role and responsibilities of the UK Responsible Person if a no-deal Brexit withdrawal from the European Union comes to pass. Get the full story here at the Emergo Group’s blog. […]
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 […]
Emergo Group launches new RAMS digital medical device RA/QA management system
By Stewart Eisenhart, Emergo Group Emergo by UL has rolled out an enhanced version of its Regulatory Affairs Management Suite (RAMS) platform to provide automated, efficient and cost-effective regulatory affairs and quality management support for medical device companies. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
FDA finalizes guidance on special and abbreviated 510(k) programs
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued final guidance for its Special and Abbreviated 510(k) premarket notification pathways following proposals in 2018 to expand access to these programs, as well as its Refuse to Accept policy for inadequate or incomplete 510(k) submissions. […]
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 […]
Medical Tubing and Extrusion: Check it out
WTWH Media is pleased to announce the newest media site in its Life Sciences business. Medical Tubing + Extrusion is your go-to source for news about innovations in the medical tubing and extrusion space — and the companies making those advances possible. Part of WTWH Media, the site is a resource of Medical Design & Outsourcing and MassDevice. “In the past […]
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 […]
Connecting the Next Generation of Medical Data and Devices to Improve Patient Outcomes
Every day, hospitals and doctors collect infinite amounts of data on individual patients, diseases and medical procedures. The rise of a new generation of robotic, precision, and surgical devices has created vast stores of video, imaging, and other electronic surgical notes, while the proliferation of digital patient technologies, such as electronic medical records, wearable sensors […]
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