In order to remain competitive in the rapidly-evolving Industry 4.0 landscape, most companies will be required to make technological changes. In the medical device industry, there are a number of unique considerations this technological change presents. This whitepaper, written by Pilgrim Quality Solutions and produced by Generis, explores the impact Industry 4.0 will have on the medical device industry, and how to make the shift to ‘Quality 4.0’. It explores areas where medical device manufacturers should focus investment; the impact on product validation and regulatory and quality compliance; and how Quality Leaders can embed operational quality into risk processes that are outside of traditional QMS. View the whitepaper to explore: Industry 4.0 – What is Industry 4.0 and What is Driving it – The Smart Factory, Cyberphysical Systems, and the Internet of Things – Effect on Products and Processes Implications for the Medical Device Industry – Focus on Digital Technologies – Data Security – Investing in Change Impact on Validation, Regulatory & Quality Compliance – Validating Smart Products – FDA Guidance – Understanding the Quality Impact of the Smart Factory – Embedding Quality in the Value Chain How to Move Toward Smart Quality Management – The Need for Automated, Operational Quality Risk Management – How Quality Leaders Can Gain Organizational Support for Quality 4.0 Initiatives – Quality 4.0 Investments to Support Industry 4.0 – Strategic Objectives Smart Quality Management, Industry 4.0 and Quality Management Systems
Read More →Optimizing Temperature Control for Biopharmaceuticals
This article first appeared in BioPharm International, October 1, Caroline Hroncich Today pharma companies are faced with an ever-changing market that includes increased regulatory challenges, globalization, and heightened competition (1). Biopharma companies are rapidly expanding into emerging markets where there are new opportunities for drug development. Conversely, logistics companies must keep up with the demand, ensuring all storage technology is equipped to retain the safety and efficacy of a drug by the time it reaches the end of its journey. This article by World Courier delves into these relevant industry topics: Common considerations for shipping biopharmaceuticals; Temperature management in extreme climates; Recent advancements; and Looking ahead. Learn more about optimizing temperature control for biopharmaceuticals in the article below!
Read More →A new, uniform packaging design boosts sales and cuts emissions
A new packaging design can make a huge difference for brand awareness, sales, and the environment. BillerudKorsnäs collaborated with a manufacturer of outdoor grilling products to develop and implement a new packaging solution from renewable, fiber based material. BillerudKorsnäs worked with a company who was struggling with inconsistent packaging and high carbon emissions. By replacing the PET and PE plastics, BillerudKorsnäs was able to produce packaging that delivered uniform results to multiple OEM locations. The company was able to increase its market share and customer base while making a sustainable contribution to the environment with more than 47, 000 kg of PET plastics removed from the packaging’s lifecycle. Read the full case study below!
Read More →Webinar: ISO 9001:2015: An Implementation Perspective
Is your organization ready for ISO 9001:2015? Have you begun preparing to transition or get certified to the new standard? This webinar by Intelex Technologies features Peter Merril, one of North America’s foremost authorities on the implementation of ISO 9001. Peter shares his expertise and insights on how to proactively jump-start your transition. The webinar topics discussed include: An outline of the structure of the new ISO 9001:2015 standard; Discussion of interpretations and new terminology; and Practical tips to help organizations transition and meet the requirements of ISO 9001:2015. Watch Now Below!
Read More →Q&A eBook with Advanced Material Solutions: The Importance of Non-destructive Testing in Manufacturing
Competitive forces are driving unheard-of levels of innovation in product design, materials and lean manufacturing processes. A rigorous and proactive approach to risk containment is essential to protect your brand and bottom line. Today’s non-destructive testing field is comprised of several commonly utilized techniques and several others that aren’t as commonly employed. Each technique has its advantages and limitations. No single method is superior, however, AMS’ expertise lies in the team’s ability to identify and deploy the ideal inspection method for each project at the best overall value. Find out more about non-destructive testing, future-proofing best practices, and financial justification in the Q&A eBook with Advanced Material Solutions below! Join us at the American Manufacturing Summit March 28-29, 2017 in Chicago, IL to hear the President of Advanced Material Solutions, Peter Miller, speak on “Future-Proofing Manufacturing Through Non-destructive Testing.”
Read More →How Medical Device Manufacturers Can Optimize Quality, Lower Costs, and Increase Efficiency
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:
Read More →eBook: Realistic Simulation for Medical Device Developers
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!
Read More →An Agile Alternative to Document-Centric Methods for Requirements Management
The American Medical Device Summit is less than one month away! The summit will draw on the knowledge of over 40 industry leaders to explore the challenges and opportunities in product development, quality management, speed to commercialization, and regulatory harmonization. One of the companies helping developers tackle the challenges in product development and compliance is Jama Software. Jama Software has developed a more agile alternative to document-centric methods for requirements management, creating the optimal environment for defining problem statements, validating cross-functional input and ensuring that what is delivered at each phase of is what was intended. Check out the Demo Video below to find out how on-boarding this software can help developers navigate complex development cycles and build great products by: Removing the overhead of requirements reviews. Shortening the time between milestones. Mitigating risk and maintaining traceability evidence. Visualizing connections between regulations, requirements and test cases. for a more in-depth look at the software, try the software yourself by signing up for the Jama Software Free Trial!
Read More →Struggling with finding a fully validated Requirements Management Tool?
Quality control and regulatory compliance are paramount in medical device development. A fully validated tool can help reduce time and effort in the initial stages of product development. Finding the right Requirements Management Tool is imperative for medical device developers operating in an extremely regulated environment. Cognition Corporation, product and process development leaders for more than fifteen years, developed the white paper below to help medical device developers navigate this terrain. Check out the Cognition Validation Kit White Paper!
Read More →The Benefits of Test Engineering Services for the Entire Product Life Cycle
Medical device developers are under increasing pressure to develop new features and better quality products while speeding time to market. One of the ways that developers are achieving this goal is by adopting automation software that will allow them to streamline their product development and test times without sacrificing quality. Averna, a Test Engineering leader, generated the video below to highlight the benefits of automation software and explain how it can help address some of the biggest challenges that medical device developers face. Check out the video below:
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