Thanks to the rapid development of wireless connectivity technologies, health devices have become increasingly mobile and accessible not just at hospitals and clinics, but also at home. Applications have been developed so that patient data are instantly available from wearables, phones and computer tablets. Remote monitoring and other types of health devices leveraging mobile technologies have been proliferating and the trend will continue to gain momentum in next 10 years. The value is tremendous in improving patient outcome and reducing healthcare costs. This webinar will discuss the opportunities and challenges for device manufacturers as they craft mobile product development strategies.
Wed, May 20, 2015 - 11:00 am
Focus on Fundamentals 3-Day Course - Practical Risk Management: How to Integrate ISO 14971 into your Product Development Lifecycle
Medical device risk management using ISO 14971 has become an industry best practice for medical device manufacturers. Adopting ISO 14971 methodology may become burdensome or complex if elements such as risk planning, risk analysis, risk reporting, and postmarket risk surveillance are implemented poorly. This practical course will highlight key deliverables and how to generate them, reference warning letters and 483s for examples of what and what not to do, and identify when and how to integrate risk management with the typical medical device product development lifecycle. Learn from David Amor, an industry consultant who specializes in helping companies such as Boston Scientific, St. Jude Medical, and smaller startups navigate through FDA remediation activities surrounding risk management.
Tue, Apr 28, 2015 - 02:00 pm - Thu, Apr 30, 2015 - 02:00 pm
60 Minutes Per Day
As a medical device manufacturer, patient safety is likely one of your biggest concerns. And while there are currently no mandatory regulatory requirements (ISO Standards), steps are being taken toward regulation. So what if your current connectors do not meet these new standards? By making a material change to Eastman Tritan™ copolyester, you can create compliant products and improve part development and molding efficiency all while increasing speed to market.
Tue, Apr 21, 2015 - 08:00 am
This webcast gives device labelers a different perspective on UDI submission. Rather than being an endpoint, UDI submission is the start of a living record – that has a lifecycle. The presentation also examines the long term benefits of UDI data as persistent, living records for use across sectors of the life sciences industry. These UDI records will be a key building block in the drive toward global healthcare interoperability.
Wed, Apr 15, 2015 (All day) - Fri, Apr 15, 2016 (All day)
Learn how new tribologically modified MT® grade copolymers are enabling quiet, smooth-sliding medical parts. The experts at Celanese, will present the latest, innovative material solution, Hostaform® MT® SlideX™ POM, and how it is delivering improved technical properties, easy processability, and increased patient comfort.
Thu, Apr 9, 2015 - 08:00 am
This webinar will highlight the purpose of having a documented validation plan in place prior to performing any package testing. We will also look at regulatory requirements, examine key considerations when designing, manufacturing, packaging, and testing your medical device, and review what needs to be incorporated into each section of the protocol.
Tue, Mar 24, 2015 - 08:00 am
When an idea for a new medical device – or reinvention of an obsolete one – arises, it can be difficult to decide its development and manufacturing destinations. Does your company have the necessary resources to take on that kind of challenge, or is it more economical to begin research on Contract Manufacturers? Essentially do you make, or do you buy? How do you choose?
Tue, Feb 17, 2015 - 08:00 am
This webinar provides a basic overview of considerations for establishing a test strategy and test plans for biocompatibility, sterilization and packaging of healthcare products. We will provide examples of some of the common mistakes which we have experienced regarding test strategies and plans. Lastly we present a practical example of developing a biocompatibility testing strategy. The information is intended to help make the regulatory submission and testing processes as smooth as possible.
Tue, Feb 10, 2015 - 08:00 am
In today’s increasingly complex market, some medical device companies fear stricter regulatory standards will compromise their ability to accelerate innovation. Fortunately, that is not true. Solid design control business practices coupled with a modern product design solution can ensure medical device companies — even those with globally disseminated supply chain teams — achieve compliance without sacrificing accelerated innovation. Join Topera’s Quality Assurance Director Ken Perino and Arena Solution’s Validation Program Manager Yelena Bolton to learn how medical device companies are balancing business and compliance with their design control process.
Wed, Jan 21, 2015 - 02:00 pm
What considerations should a medical device OEM keep in mind when designing a package ready for sterilization and sale to the final customer? This webinar addresses many of the items that a device designer should keep in mind when getting a product ready for presentation to a contract manufacturer. Design for robust device packaging can save hundreds of thousands of dollars in reworked projects and timelines and can eliminate costly field corrective actions.
Mon, Dec 15, 2014 - 08:00 am - Tue, Dec 15, 2015 - 08:00 am
Modern drug delivery devices, such as injector pens and inhalers bring effective drug delivery to millions of patients each day. Although very effective for many patients, they are not designed for all drug types or all types of users. When smart systems are added to the mechanical parts, these devices can be become effective for the delivery of drugs while expanding the user base.
Tue, Dec 9, 2014 - 11:00 am - 12:00 pm
This webinar will examine how the “Big Three” biocompatibility tests (cytotoxicity, sensitization, and irritation) are advancing and what those advancements mean for medical device manufacturers. In addition to the Big Three, course registrants will learn about the in vitro sensitization/irritation testing model, and what is being done to ensure regulators accept in vitro alternatives. Additionally, registrants will receive insight into the value of in vitro testing as a means of reducing testing costs, and accelerating time to market.
Thu, Nov 20, 2014 - 02:00 pm
Material Selection and Advanced Assembly for Body-Worn Devices: How Medical Manufacturers Can Improve Their Products to Enhance Patient Care
Medical manufacturers specifying the adhesive components for body-worn devices must factor patient wear time, adhesion strength, and skin condition. This webinar covers the importance of materials selection from experts at 3M, as well as the converting processes, assembly services, and the quality/testing procedures required to ensure body-worn medical devices can be brought to market quickly, cost-effectively, and in full compliance.
Tue, Nov 4, 2014 - 02:00 pm - 03:00 pm
In this webinar Jeff Schipper, Proto Labs LSR Product Manager, will present the ins and outs of liquid silicone rubber molding. He will go over the manufacturing process, materials offered, design considerations, and how LSR can benefit the medical industry. He will also cover Proto Labs suite of services and discuss their Fineline additive manufacturing, Firstcut CNC-machining, and Protomold injection-molding services.
Mon, Oct 27, 2014 - 08:00 am - Fri, Oct 16, 2015 - 08:00 am
Most medical devices require some form of pad printing to mark biohazard labels, measurement indicators, part identification information or required branded logos. But some complex devices pose a challenge to accurately and cleanly print upon. In this webinar we will identify ideal pad printing candidates, and provide an overview of the pad printing process. The webinar will also address common pad printing obstacles, and offer best practices for printing on devices with difficult surfaces, shapes or sizes.
Tue, Oct 14, 2014 - 08:00 am - Wed, Oct 14, 2015 - 08:00 am
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