“Validation is required, as regulated by FDA, to ensure that a company’s product development software/system will meet its intended purpose. The software/system must show that it will function in a reliable, consistent manner and is in compliance with regulatory and business requirements. Additionally, once the software/system has been accepted and released for use, there is a need to maintain compliance and fitness throughout its operational life. Unfortunately, information on how to develop a validation plan and the activities expected as part of a validation effort are limited and subject to misinterpretation.” Are you struggling with finding a fully validated Requirements Management Tool? If so, check out the full white paper by Cognition!
This PDF by Averna will delve into: Higher and higher frequencies More RF standards, fewer test resources Increased Takt time and slower throughput Capturing large instantaneous bandwidths Streaming large amounts of RF data Click on the link below to check out the full PDF about the major test challenges for RF products! http://bit.ly/2eLmdmy
Industry regulations can make life for medical device manufacturers very challenging. Regulations are there for a reason and are required to grow and improve your business. This is different than in most manufacturing sectors. Demonstrating compliance to these various regulations requires meticulous record management. As an example; the ability to easily manage and maintain your records for Product Design, can provide an organization with a competitive edge for getting new products, or enhancing existing products for their market. QT9 Software will be speaking at our American Medical Device Summit taking place October 4-5th, 2017 in Chicago, IL. The presentation topic will be on the “Benefits of Automating Your Quality Management System with Software.” We asked Brant a few questions about quality management, issues medical device manufacturers are facing today, and how to save time and money in the industry. Please, take a look at our Q&A eBook with Brant Engelhart from QT9 Software below!
At Generis’ American Medical Device Summit 2016, we sat down with Dr. Steve Levine, Senior Director of Product Strategy and Executive Director of the Living Heart Project at Dassault Systèmes and discussed scientific innovation initiatives such as the Living Heart Project, realistic simulation, and technology’s role in the industry. Check out the full video below!
The medical device manufacturing world can be a competitive space, and it can be difficult to stay afloat among other competitors. In this executive brief by Copley Consulting, you will find out more about key initiatives that will allow you to maintain a strong, competitive position in this space. With next-generation ERP systems that include the newest analytics and tools for collaboration, you can meet Baby Boomer demand while controlling costs. Key highlights include: Improving agility; Fostering collaboration; Keeping up with changing demands; Lowering costs and reducing lead times; and Gaining a competitive edge. Find out more about these key themes and ERP systems in the full brief below:
For medical device manufacturers, advancing and maintaining information management solutions that are compliant with an evolving set of FDA regulatory standards is a constant challenge. As you strive to manufacture high-quality medical devices, you need an enterprise resource planning (ERP) solution that can help you minimize compliance risk, as you maintain profitability, drive efficiencies, and streamline all parts of your business. This article will delve into: Upholding GMP quality standards; Maintaining regulatory compliance; Using integrated electronic records; and Meeting regulatory requirements. To find out more about how to reduce compliance risks and meet regulatory requirements, check out the white paper by Copley Consulting Group below:
Medical device manufacturing has minimal tolerance for error—and quality is of the utmost importance. If your products don’t deliver what you promise, lives can be at stake. At the same time, product returns erode your profit margins, while customer satisfaction can make—or break—your reputation. For companies with unique patented products, meeting demand puts added pressure on every stage of your supply chain. This white paper by the Copley Consulting Group explains how you can make a commitment to lean processes while raising your quality standards, improving efficiency, and driving down costs. It’s important to create efficiencies in your manufacturing processes, but this often involves taking small incremental steps. Find out more about educating your organization about these opportunities, driving down costs, and systematically removing waste and uneven workloads from your manufacturing processes below:
Today, medical device developers use realistic simulation solutions from SIMULIA to accelerate the overall product innovation process, reduce development costs, and improve patient safety and product quality. This Q&A eBook with Dassault Systèmes explores realistic simulation and its massive potential to dramatically transform healthcare. Included is a video where Dr. Steve Levine, of Dassault Systèmes, discusses 3D Design and Collaborative Platforms to Support Digital Health at Generis’ American Medical Device Summit 2016. Check out the eBook and the video below!
This informative article speaks about four key ways to build better relationships with your suppliers: Whether you are a startup medical device manufacturer or a Fortune 1000 corporation, establishing and preserving progressive relationships with your suppliers is critical to your success. Not only are you managing your inventory levels to make sure that you always have the right components in stock to meet orders, but at the same time you’re managing compliance regulations and customer satisfaction. Your relationship with your suppliers is a crucial part of how you manage these challenges. It’s time to start building better relationships so that you can establish trust and over time, the supplier will begin investing more to ensure your success. Find out more below!
It’s important to keep up with compliance mandates because the US Food and Drug Administration (FDA) keeps a close watch on the medical device industry. If there is an accident involving your devices, it could damage the lives of your patients and the reputation of your company. This article focuses on the most significant FDA quality regulatory programs to be aware of, and tips on how to avoid fines and court action for non-compliance. Read the full article here. For more information about keeping up with regulations, visit The Copley Consulting Group and Infor CloudSuite Industrial for Medical Devices.