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The Future of Medical Device Manufacturing

In compliance, cost reduction, manufacturing, medical device, medtech, mfg, technology by GenerisLeave a Comment

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: 

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Infor CloudSuite Industrial (SyteLine) for Medical Devices

In cost management, cost reduction, manufacturing, marketing, medical device, medtech, quality, Quality Management System, Quality System Management, risk management by GenerisLeave a Comment

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:

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How Medical Device Manufacturers Can Optimize Quality, Lower Costs, and Increase Efficiency

In emerging technology, Generis, healthcare technology, innovation, Lean manufacturing, Life sciences, manufacturing, medical device, medtech, mfg, product development, production efficiency, Quality by design, risk management by GenerisLeave a Comment

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:

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eBook: Realistic Simulation for Medical Device Developers

In compliance, costing, Generis, manufacturing, marketing, medical device, medtech, mfg, quality, Quality by design, safety, system design, technology by GenerisLeave a Comment

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! 

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Effective supplier management for medical device manufacturers

In manufacturing, medical device, medtech, mfg by GenerisLeave a Comment

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! 

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Top Medical Device Industry Regulations—and Why They Matter

In manufacturing, medical device, medtech, Quality System Management, risk management, safety, testing by GenerisLeave a Comment

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.

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SMTC Presentation: Driving Product Optimization Through Early Stage Supplier Engagement

In Generis, generis group, healthcare technology, innovation, manufacturer, manufacturing, manufacturing operations, medical device, medtech, product design, product development by GenerisLeave a Comment

Exploring Design for Excellence (DFX) Brian Morrison, from SMTC, took his wealth of knowledge and understanding as the Director of Value Engineering & Technology and presented crucial industry information at the American Medical Device Summit 2016. Take a look at Morrison’s insightful presentation from the Summit that explores Design for Excellence (DFX) Product Optimization, focusing on these core concepts: What is DFX? DFX Benefits Value Equation Product Design Review Ability to Impact Product Value Early Supplier Involvement (ESI) Impact of Design Decisions Applying DFX to Product Development To view the full presentation, click here. About SMTC SMTC is a mid-size provider of end-to-end electronics manufacturing services (EMS) including PCBA production, systems integration and comprehensive testing services, enclosure fabrication, as well as product design, sustaining engineering, and supply chain management services.

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Maetrics: The ROI of Good Quality & Compliance

In manufacturing, medical device, medtech, mfg, Quality Management System by GenerisLeave a Comment

On October 5th, 2016 at the American Medical Device Summit in Chicago, Generis welcomed Maetrics to the speaker panel on Day One. Ed Roach, the Managing Director of Maetrics, focused his presentation on four main objectives being: Ideas on how to quantify the costs of quality for investment justification Understanding indirect or potential costs of quality and compliance including Examining FDA’s recent and future approach to Medical Devices The Potential Impacts of FDA’s approach to Medical Devices Understand the Benefits of a Proactive Quality System Benchmarking – Good Investments in Quality and Compliance To view the full presentation online, click here. Panel Speaker: Ed Roach, Managing Director of Maetrics Ed Roach brings nearly 20 years of experience in the life sciences industry to the panel while adding his wealth of knowledge on Quality Systems and Quality Assurance, Validation, Corrective and Preventive Actions (CAPS), Root Cause Investigation, Change Management, and 483/Warning Letter Remediation to the American Medical Device Summit. Generis is thrilled that Maetrics will be returning to Chicago for the American Medical Device Summit on October 4th and 5th in 2017. For more information on Generis or our American Medical Device Summit taking place in 2017, please, don’t hesitate to contact us today.

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eBook: Realistic Simulation for Medical Device Developers

In design engineering, Design Thinking, innovation, Life sciences, manufacturing, medical device, medtech by GenerisLeave a Comment

Medical device developers use realistic simulation solutions from SIMULIA to accelerate the overall product innovation process, reducing development costs, and improving patient safety and product quality. In addition, SIMULIA provides medical device companies with the ability to more efficiently evaluate design alternatives, accelerate long-term stress life testing to predict product reliability, collaborate on projects and leverage computing resources for more efficient design analysis. Check out the eBook below!  

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Enabling the Use of Engineered Plastics in Medical Device Manufacturing

In Engineered Plastics, manufacturing, medtech, Plasma by GenerisLeave a Comment

Plasma is a versatile tool that is capable of designing controlled interfaces on a variety of materials used in medical device manufacturing. This includes replacing conventional multistep wet chemistries. Plasma gives the medical device designer freedom to separate mechanical, optical, and fabrication techniques from the surface requirements that often require compromises in cost and performance. Check out the PlasmaTreat whitepaper below for insights on enabling the use of engineered plastics in medical device manufacturing.

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