Improving Compliance with Increased Global Regulations
Today’s medical device companies must deal with increased product complexity and evolving global regulations. To deliver cutting-edge solutions, companies must comply with quality management system requirements like ISO 13485:2016, while meeting corporate and production objectives. Medical device companies strive to improve patients’ lives by leveraging the latestquality management systems (QMS) to deliver innovative solutions to market while maintaining compliance with the FDA and ISO regulations. Using outdated document-centric QMS solutions hinders product development, quality, and production processes. How can you improve compliance and performance?
Wed, Oct 4, 2017 - 02:00 pm
Duration: 60 Minutes
Sponsored by: Arena Solutions
This three-day webinar will provide engineers and QA/QC/RA managers with an overview of medical device and pharmaceutical industry trends, updates, and anticipated changes. Four major topics will be covered in three days, including: biocompatibility assessments, sterilization methodologies, packaging integrity testing, and medical device cleanliness testing.
Learn the most up-to-date information about these topics from the Nelson Labs’ experts who sit on the domestic and international committees that set the standards for the industry. These experts understand the day-to-day regulations that impact manufacturers and will be providing relevant, current information for attendees. Come prepared with questions, as ample time for your questions will be provided at the end of each webinar.
Tues, September 26 - Thurs, September 28 - 02:00 pm each day
Duration: 60 Minutes
Sponsored by: Nelson Laboratories
IC-DISC basics. Tax Benefits for US Based Exporters
This webinar an introductory overview of the elements of an Interest Charge Domestic International Sales Corporation (IC-DISC) and a discussion of the profile of companies who might benefit from such a structure.
Wed Sep 6, 2017 (All day)
Duration: 30 Minutes
Sponsored by: Sil-Pro
How to Keep Pace with Change in Med-Tech: Industry Challenges and Manufacturing Solutions
Find out how the medical device market can be prepared to innovate faster and more efficiently through the use of closed-loop manufacturing processes. See how Siemens helps you to cope with this increased rate of innovation, to manage product changes as a set of data instead of documents.Learn how your peers have succeeded in this changing environment by focusing on improved product outcomes while simultaneously supporting shorter innovation cycles. See how they employ closed-loop integrated systems that allow for real-time decision-making, based on real intelligence.
Tue, Jul 18, 2017 - 02:00 pm - Wed, Jul 18, 2018 - 03:00 pm
Duration: 60 Minutes
Sponsored by: Siemens PLM Software
What You Need to Know About Establishing a UDI System
Are You Ready to Embrace a UDI System? This webinar is perfect for you if you're a medical device manufacturer or health care distributor. Your company’s success depends on meeting the challenging demands of your industry. Such challenges include regulatory compliances, strict quality assurance requirements, short product life cycles, and multiple subcontractors.
Wed, Jun 7, 2017 (All day) - Thu, Jun 7, 2018 (All day)
Sponsored by: Southeast Computer Solutions
Medical Device Disinfection for Reprocessing Products for US and EU
This webinar is designed for engineers, quality assurance personnel, microbiologists, and marketers of reusable medical device manufacturers to deepen their knowledge about disinfection validation methods for reprocessed devices. Specifically, attendees will better understand disinfection validation standards and practices in the United States and Europe: US FDA Guidance from 2015, AAMI TIR12, AAMI TIR30, ISO15883, among others. Validation techniques and information regarding chemical, thermal, and A0 disinfection testing will be explained.
Thu, Jun 1, 2017 (All day)
Duration: 15-minutes
Sponsored by: Nelson Laboratories
Drowning in Big Data: Extracting Medical Device Quality and Safety Insights
There’s a daunting amount of data out there about medical device quality and safety. Public sources such as FDA and private databases house valuable information about adverse events, recalls, inspection findings and warning letters. But this data can be difficult to locate, standardize and compare. We’ll examine the available safety and quality data sources, what they can tell us, challenges with analyzing the data and what you can do to overcome these challenges.
Wed, Apr 12, 2017 (All day) - Thu, Apr 12, 2018 (All day)
Duration: 60 Minutes
Sponsored by: LexisNexis
This webinar from Leica will clear up common misconceptions about digital magnification, resolution and megapixels, and explain why optics in digital microscopes are still the key driver in achieving reliable results in your inspections. Our product and application experts will tell you what you really need to know about imaging performance parameters so that you'll be able to make the right decisions when selecting a digital microscope for you specific application.
Tue, Apr 4, 2017 (All day) - Wed, Apr 4, 2018 (All day)
Duration: 60 Minutes
Sponsored by: Leica Microsystems
Considerations for Third-Party Reprocessing Of Single-Use Medical Devices
Reusing single-use devices that have been safely reprocessed by a third-party reprocessor can enable healthcare providers to maintain high-quality patient care while saving on costs and reducing medical waste. This webinar will navigate through the required validation aspects to reprocess single-use devices safely and effectively.
Thu, Mar 30, 2017 (All day) - Sat, Mar 30, 2019 (All day)
Duration: 20-minutes
Sponsored by: Nelson Laboratories
Risk Management for Medical Device Manufacturers
The three day course – on Risk management is an important and challenging topic for all medical device manufacturers. But what is risk and how do we manage it? There are many connotations of risk and many methods used to manage them. Although there are "industry standards" such as ISO14971 and others, risk remains a source of confusion for manufacturers and regulators alike. During this 3-part interactive webinar, a more systematic, engineering-minded approach to risk is presented using multiple examples of medical devices to demonstrate important concepts. Ultimately risk is not a simple matter! Following the webinar, participants will have a much better appreciation of the importance of risk and how to manage it.
Tue, Mar 28, 2017 (All day) - Wed, Mar 28, 2018 (All day)
Duration: 60 Minutes Per Day
Sponsored by: EtQ
3 Steps for Designing the Ideal Medical Device Packaging System
CleanCut Technologies will present 3 important steps to consider when designing your ideal medical device packaging system, including why it is critical to plan early, the importance of properly sized packaging, and utilizing a robust testing protocol. If you are part of a design or new product team, you’ll want to join us for this informational webinar!
Wed, Mar 1, 2017 (All day)
Duration: 15-minutes
Sponsored by: CleanCut Technologies, LLC
Reducing Device Cost with Innovative Medical Materials
Polycarbonate and PET are well-known materials to medical device material specifiers and has been used for decades. In many applications, polycarbonate and PET are more highly engineered resins compared to actual application needs. Innovations in medical materials have produced viable alternatives to polycarbonate and PET in applications where high impact, chemical and heat resistance are not needed. This webinar is designed to educate engineers, product managers and material specifiers charged with reducing medical device costs and who are interested in considering new materials which may be more appropriate for their design goals.
Wed, Feb 15, 2017 (All day)
Duration: 30-minutes
Sponsored by: Entec Polymer
Automating your Quality Management System: Pitfalls & Essentials
Learn the pitfalls to avoid and essentials steps for long term success when planning and implementing software automation within your quality management system (QMS): Where should you begin? Which quality processes should you automate and integrate, and in what order? What are the critical considerations for technology, compliance and validation? What should you do—or not do—to ensure a smooth transition from manual to electronic quality management?
Tue, Jan 24, 2017 (All day)
Duration: 30-minute
Sponsored by: AssurX
3D Printing for Surgical Devices and Medical Models
In this 55-minute webinar, Dr. Frank Rybicki, Chief of Medical Imaging at Ottawa Hospital, will share insights, examples and benefits of 3D printing in the medical field. He will discuss the role of 3D printing in medicine, particularly in hospitals, several models for hospital-based 3D printing programs and current trends and future paths for 3D printing. As well as share benefits such as less time in the operating room, fewer post-operative complications and avoidance of unnecessary surgery.
Thu, Dec 15, 2016 (All day) - Fri, Dec 15, 2017 (All day)
Duration: 55-minutes
Sponsored by: Stratasys
The Power of Extractable/Leachable Chemistry Testing for Medical Devices
This presentation will teach you the three most important points of extractable/leachable chemistry testing for medical devices: how it will save you time and money, how it provides detailed information that protects patient safety, and how it will keep you at the front of an evolving approach to the evaluation of biocompatibility.
Thu, Dec 8, 2016 (All day) - Sat, Dec 8, 2018 (All day)
Duration: 35-minutes
Sponsored by: Nelson Laboratories
FACT: 60% of a device's cumulative lifetime cost is committed in the concept/architecture phase. You need to break out from traditional "trial and error" product development in order reduce the margin of error...and cost. Teleflex Medical OEM has the solution: a Customer Solution Center with proven processes for reducing project risk, minimizing costs, and getting your device to market faster. During this information-filled webinar, you will learn about: Data-based decision making utilizing a proprietary database of device performance characteristics • How the application of a proven, nine-step, solution-oriented process can deliver a device that meets clinical needs and your requirements • The advantages of working with an external development resource to deliver innovative devices
Tue, Nov 8, 2016 - 11:00 am - 12:00 pm
Duration: 45-minutes
Sponsored by: Teleflex Medical OEM
Changing a Colorant in an Approved Medical Device, What Should I Know?
In this webinar we will examine the unique challenges colorants pose to medical devices, including FDA's current position on changing a colorant or pigment. The webinar will cover topics such as possible impacts to human health, how testing can mitigate risk to patient, toxicological risk assessment and choices available for chemical analysis.
Thu, Oct 27, 2016 (All day) - Fri, Oct 27, 2017 (All day)
Duration: 30-minutes
Sponsored by: Nelson Laboratories
Innovating within Cost Constraints to Get More Bang for Your Buck
Delivering innovative new medical devices to market on time and on budget is at the top of every CEO's agenda. But medical device development isn't easy. Engineers! Attend this webinar to learn practical ways to reduce the risk and cost of innovation when developing medical devices, including: how to minimize the number of iterations under formal design controls, why you shouldn’t love your prototype, and how to avoid common time and money wasters.
Wed, Oct 5, 2016 (All day) - Thu, Oct 5, 2017 (All day)
Duration: 40-minutes
Sponsored by: Creation Technologies