Thor Rollins, biocompatibility expert with Nelson Labs, will provide insights on biocompatibility testing and where the ISO/TC-194 working group plans to take the ISO 10993 standard in the future, and Allison Komiyama, regulatory consultant with AcKnowledge Regulatory Strategies, will break down the FDA’s recently released “A-list” guidance documents and discuss how recommendations may impact medical device manufacturers.
Tue, Aug 25, 2015 - 02:00 pm
This webinar will review the features and performance capabilities of a new, fully programmable small chamber (5 cubic feet or 8 cubic feet) ethylene oxide sterilizer system. Find out how this sterilizer for in-house and contract sterilization provides flexibility in cycle design, chamber uniformity, is engineered for safety, has detailed record keeping and also meets standards requirements.
Thu, Aug 20, 2015 (All day)
Most medical device companies are faced with a challenge. They have a growing number of new products and an increasingly dynamic global supply chain but at the same time, regulators demand robust device history records (i.e., eDHR) and UDI labeling and traceability. This webinar will show you how to satisfy regulators, reduce costs, improve quality and foster continuous improvement through modern and consistent manufacturing information systems.
Tue, Jun 30, 2015 - 08:00 am
New trends in cleaning, disinfection, and sterilization of reusable medical devices present new challenges in designing products that meet customers’ expectations for life expectancy in the field. It also requires innovative approaches to qualification protocols that can accurately reflect performance. This webinar will give a basic understanding of the chemicals and operating conditions of commonly used reprocessing procedures. Case studies will share how design and material choices can affect sterilization durability of the final product.
Thu, Jun 25, 2015 (All day)
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
Learning from Hospital Acquired Infections (HAIs): Understanding Current Reprocessing Regulations, Product Validation and Clinical Human Factors
Watch this exclusive on demand webinar where it will provide an overview of Hospital Acquired Infections, human factors issues encountered in device design and in the healthcare facility, and how to perform a validation for a reusable medical device for use in the healthcare facility. Information on test procedures as well as US and EU regulatory requirements, including new guidance from FDA, will be provided.
Tue, May 19, 2015 - 08:00 am
This webinar is intended for medical device manufacturers of high-value physician preference items (PPI) who employ trunk stock and consignment inventory. In this webinar, John Smith, Director of Supplier Solutions for WaveMark, Inc., will examine the common challenges faced by medical device manufacturers in managing field inventory. He will recommend best practices and review how manufacturers are deploying cloud-based mobile software, enabled by RFID technology, to take control of their field inventory while controlling costs.
Thu, May 14, 2015 (All day)
As x86 systems- processors, memory, and I/O technologies (cables, radio, etc.) have evolved, the embedded world has absorbed these in various forms and in some cases taken an entirely different approach. In this presentation we explore some of the history of x86 influences on embedded systems as well as new approaches and markets that the embedded world has created.
Tue, May 12, 2015 (All day)
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
- Maximize Industrial IoT Development Effectiveness with Integrated ALM and Virtual Labs - Webcast
- Why Devices are Failing in Oncology Drug Delivery Applications - Webcast
- Three Things to Know When Selecting a Customized DC Motor Drive System for Your Application - Webcast
- MD&M West - Event
- Active Implantable Device Technology Development: Mechanical and Manufacturing Perspectives - Webcast
- Five Key Considerations for Evaluating and Selecting the Most Effective Electronic Quality Management Systems for Medical Device Manufacturers - Webcast