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 […]
Devices Roar Into The Next Decade
Medical device investments skyrocketed in 2018, and these trends are continuing into 2019. The activity now will influence healthcare for the next decade. This year, the medical device and diagnostic industry saw record-breaking increases in the investment scene. As noted by Silicon Valley Bank’s (SVB) analysis, Trends in Healthcare Investments and Exits 2019, investing in […]
Life in the Fast Lane: 3 Lean Tools to Speed Products to Market
By Don Welling, Sr. Director of Technical Solutions, Viant The average driver can change a tire in about 20 minutes. A NASCAR pit crew can change all four tires in less than 20 seconds, thanks to the right tools and processes. Of all the tools used in NASCAR racing, the air wrench has saved the […]
The need for new business models under MDR/IVDR
In less than 12 months, the world’s second largest market for medical technologies is going to be turned upside down. The new medical devices regulation (MDR) and in vitro diagnostic device regulation (IVDR) — which set forth more stringent safety and data requirements for devices distributed in the EU — will go into effect in […]
5 Guidelines for Writing a Useful Clinical Monitoring Report
Taking Your Report from Good to Great By Brandy Chittester, Chief of Clinical Operations A well-written monitoring report is an essential part of documenting clinical trial oversight. In addition to being required by ISO and ICH guidelines, it also tells the story of the clinical trial to the FDA, demonstrating site performance and sponsor oversight […]
Design for Manufacturing Breakthroughs
Producing Innovative Micro Medical Devices By Lindsay Mann, Director of Sales & Marketing How to Overcome Roadblocks When Producing a Micro Medical Breakthrough When trying to produce an innovative micro medical design, you may come to a roadblock. What can you do to move forward and get the project back on track? First, determine the […]
Global Excellence in Delivery Device Testing
Introduction There is a need for a fully-informed laboratory in combination device validation services. The ideal is a laboratory that understands both the pharmaceutical and medical device requirements; from extractables and leachables, through bioavailability, to dose accuracy and ease of use. A good pre-clinical partner/test facility, such as Medical Engineering Technologies Ltd. (MET, www.met.uk.com) can […]
The Promises (and Problems) of Real World Data
By David Kronfeld, Head of Real World Data Innovation, Medidata Solutions Medtech is just starting to access the rich well of real-world data (RWD), which offers some incredible opportunities to build more successful and useful devices. RWD technology can be employed to improve patient recruitment, efficiently deploy a sales team, identify unmet needs in regions, […]
Putting patients first – e-consent in clinical trials
Medical device developers do not always consider the process of informed consent for clinical trials, since it is often handled at the trial site. But the industry is changing, and digitizing processes such as informed consent can streamline studies to rapidly collect quality data, while reducing costs. Patient-centric healthcare means patient-centric clinical trials As the […]
Preparing for EU MDR Product Submissions: A Sustainable Approach
By Michelle Boucher, VP of Research for Tech-Clarity Every medical device company wanting to do business in Europe must comply with the new EU MDR regulation. Yet this is no small feat considering the more stringent requirements. While the new regulation is largely an extension of the existing regulation, it requires far more data. As […]
How K2M Tackled UDI and What Comes Next with help from Reed Tech
Mark Zellers, Quality Assurance Specialist at K2M, is responsible for ensuring his company’s data is accurate and kept up-to-date with all sorts of outside stakeholders. One of his colleagues handles internal data management and Zellers ensures it gets to the people who need it outside K2M. A big challenge facing his team came in 2015, […]
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