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 […]
Outcome-based Pricing Initiatives in the Healthcare Industry
By Joe Miles – Global Vice President, Life Sciences (SAP Industries) and Bob Steller – Industry Principle, Life Sciences (Vistex) A distorted reimbursement model has driven healthcare costs ever higher, and elevated healthcare spend to the top budget item for many governments across the globe. But several major industry players have begun to experiment with […]
Clinical Study Cleanup: How to Get Your Study Back on Track
By Kelly Jasko, Lead Clinical Research Associate Every year, the U.S. Food and Drug Administration (FDA) releases metrics detailing the outcomes of the Bioresearch Monitoring (BIMO) inspections done at facilities conducting clinical research within the previous year. Of the 104 Sponsor/Monitor/Contract Research Organization (CRO) inspections done in fiscal year 2017, 36 percent were found to […]
Silicone Materials for Long-term Medical Implants: Innovate for the Future
By Feifei Lin, Ph.D., Business Development Manager, Healthcare, Elkem Silicones USA Corp. With the growth of the aging population, the number of age-related diseases has increased. Every year millions of patients sustained or improved their lives through surgical procedures involving implanted devices. Medical implants such as orthopedics, pacemakers, cardiovascular stents, defibrillators, neural prosthetics or combinational […]
Delivering Quality – The ISO 13485 Certification
By Charlie Sears, Quality Manager, Goddard Inc. The medical device industry is one of the most highly regulated verticals worldwide. Devices and quality systems must satisfy stringent requirements before they can be marketed and sold in the U.S. and worldwide. The ISO 13485 standard specifies requirements for a quality management system (QMS) for an organization […]
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