Medical device developers are evolving and introducing new products and variants into the market. With this evolution comes a more complex and dynamic global supply chain. To help navigate this shifting terrain Dassault Systèmes generated the free webinar below to help guide developers through effective techniques to create an opportunity through traceability. Check out the 35 minute free Qmed webinar on Making Traceability Work for the Business: Effective eDHR and UDI to discover: The role of integrated manufacturing software in eDHR and UDI compliance Approaches to consider for traceability program improvements Questions to raise as you assemble the diverse stakeholders for such a project Check out the Webinar!
Read More →The Myths and Facts of Manufacturing in Mexico
Deciding on the appropriate region for your manufacturing operations is a vital step. Many US manufacturers consider Mexico when deciding on plant locations because of its proximity to US markets, access to resources and skilled labor, as well as the favorable trade agreements. But is Mexico the best decision for your organization? To help manufacturers make an informed decision American Industries developed the eBook below which outlines the benefits, issues, myths and facts about manufacturing in Mexico. Download the eBook below to gather the information you need to make an informed decision on whether Mexican manufacturing is the right decision for you.
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 →Big Challenges for Testing Today’s Wearable Devices
Wearable devices have become a commodity; devices act as fitness and health trackers, work and lifestyle guides as well as medical monitors. According to The Business Insider the “global wearables market will grow at a compound annual rate of 35% over the next 5 years”. This growth will bring a range of lifestyle enhancing and potentially life-changing accessories directly to consumers and to the healthcare industry at large. As the market evolves, developers and manufacturers will find themselves faced with an array of functionalities and processes that need to be rigorously tested in order to ensure consumer satisfaction, safety and regulatory compliance. Averna, a Test Engineering Leader, generated the whitepaper “High Tech, Will Travel” to outline some of the current and upcoming challenges in testing wearable devices. A brief preview is below, click on the image or link to Download the full whitepaper! We are thrilled to have Averna join us at the upcoming American Medical Device Summit 2016! To find out more about the summit and join the discussion this October 5-6, visit: http://amdsummit.com/
Read More →Legal Entity Frameworks for Manufacturing in Mexico
Setting up manufacturing operations in Mexico requires an initial assessment of the appropriate legal entity framework; manufacturers have the option to work with a shelter legal entity, or work with as own legal entity. American Industries is a group has helped more than 200 manufacturing companies successfully establish and run operations in Mexico. The eBook below has some great insights to help manufacturers asses the right framework, and make the right decision for any Mexican operations. If you are considering manufacturing operations to Mexico, check out the Legal Entity Framework eBook!
Read More →Major Test Challenges for RF Products
Automotive consumers are demanding, and are placing OEMs under increased pressure to provide enhanced value through the use of RF technologies. Remote keyless entry, CAN/VAN networking and self monitoring operations are all considered standard in automobiles newly entering the market. For OEMs this means an increase in the composite parts and that need to be integrated into their designs as well as months of development, integration, prototyping and testing. Ensuring the successful installation of an RF system can enhance safety, avoid recalls and ensure consumer satisfaction. Averna specializes in test engineering and is all too familiar with the challenges that OEMs face when it comes to the effective testing of RF products. The ebook below was created by Averna to discuss some of the major challenges in RF Product testing and highlight key strategies to overcome them. Check it out! Download the eBook Here!
Read More →Whitepaper: Beyond the ID, The Value of UDI
There has been a great amount of discussion around the impact that UDIs will have on medical device developers, manufacturers and the health care system at large. The following whitepaper takes a different approach and looks at UDI implementation from a strategic perspective to assess its true value. Check out the whitepaper below, generated by Dassault Systèmes and Axendia, to understand where the true value in this system will be expressed.
Read More →7 Tips for Transitioning to Electronic Medical Device Reporting
In August 2015 the FDA’s Center for Devices and Radiological Health (CDRH) implemented a requirement for manufacturers and importers of medical devices to transition away from paper reporting, and to instead submit adverse event reports electronically. The electronic transmission of adverse event reports coupled with the mandatory reporting deadlines will allow the FDA to respond more readily to adulterated, misbranded or unsafe devices. Pilgrim Quality Solutions, created the eBook below to help manufacturers and importers transition to electronic medical device reporting. Check out the eMDR e-book! 7 Tips for Transitioning to Electronic Medical Device Reporting For more medical device strategies, join Pilgrim Quality Solutions at the American Medical Device Summit taking place on October 5-6 in Chicago, IL.
Read More →eBook: Medical Device Commercialization Best Practices
The evolving regulatory landscape and the accelerated pace of medical device innovation are increasing pressure on medical device developers to speed their time to market while providing higher quality products, at less cost. Navigating this shifting terrain and enabling a quick time to market can often be a challenge. In this eBook, we sat down with Cognition Corporation, compliance and medical device solutions specialists, to gather their insights on the commercialization challenges that medical device developers face and the best practices to overcome them. Check out the eBook below: Medical Device Commercialization Best Practices
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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