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 →Case Study: How to lead progressive changes through project leadership
“Big new legislative requirements mean big changes at even the most efficiently run companies. But when the company uses project leadership to incorporate those changes into its larger business strategy, the benefits go far beyond compliance.” To learn more about the benefits from project leadership, check out the case study by Integrated Project Management, click here.
Read More →Q&A eBook with QT9 Software: Benefits of Automating Your Quality Management System with Software
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!
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 →Case Study: How to Get Started with Quality Performance Management
In an effort to catch quality nonconformances earlier and reduce cost, companies are focused on collecting as much performance data as possible. This data is often leveraged by quality and continuous improvement professionals to derive intelligence. Unfortunately, the conversion from data into intelligence is where many fall short. LNS Research’s recent studies and discussions with industry executives have shown that despite any data collection efforts and technological capabilities, many companies lack a strong performance management foundation for transforming information into something actionable. To gain a better understanding of the foundations of a strong quality performance management program, this report will focus on highlights from the recent LNS Research Global Executive Council meeting. Specifically, readers of this case study will gain insights into the following areas of quality performance management: An overview of Accuride’s quality performance management program Identifying the right metrics for your organization The importance of focusing on both process and product losses An understanding of how much data is required to get started Recommendations and the role of technology in performance management View the full case study below!
Read More →Infor CloudSuite Industrial (SyteLine) for Medical Devices
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:
Read More →Maetrics: The ROI of Good Quality & Compliance
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.
Read More →eBook: How Quality is Your System?
With the American Medical Device Summit 2016 right around the corner we wanted to take some time to sit down with Clarkston Consulting to gather their insights on quality system management. Clarkston Consulting are specialists in management, operations, and implementation consulting services for life sciences and consumer products companies. To help guide medical device developers on their quality journey we asked Clarkston to adress: What to Consider in your Quality System Lifecycle Quality Systems Planning and Priorities What Are the Challenges and How Can You Overcome Them? The Benefits of the Lifecycle Approach Quality Acceleration and Overwatch Check out the eBook below!
Read More →Optimize Your Lean! Marry 5S Programs, Kanban Systems and Kamishibai
You may be familiar with how 5S Programs, Kanban Systems and Kaizan Events help drive your lean manufacturing processes, but how familiar are you with the Art of Kamishibai? Once standardized work has been developed and documented, how does your company ensure that it’s sustained? This is where kamishibai comes in. Check out the infographic below, courtesy of Phase 2 Medical, to understand how kamishibai is implemented and how it can enhance your lean manufacturing efforts. The Art of Kamishibai in Medical Device Manufacturing Interested in finding out more? Contact Phase 2 Medical for more information. If you are attending the American Medical Device Summit in Chicago this October, don’t forget to stop by Booth #30 to say hello to Phase 2 Medical in person!
Read More →eBook: A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences
Medical device manufacturers are operating in a constantly evolving environment. Aging populations, evolving healthcare systems and more stringent regulations will have a significant impact on how medical device developers operate and succeed in the years to come. With the American Medical Device Summit quickly approaching, we wanted to take a closer look at how medical device developers will be able to navigate and thrive in this shifting terrain. Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services, generated the eBook below to help developers address their most pressing challenges and enable a new collaborative model. Check out the eBook!
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