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 - 02:00 pm
Quality with Confidence – What You Need to Know About Digital Microscopes for Medical Device Quality Processes
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 - 10:00 am
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 - 02:00 pm - Thu, Mar 30, 2017 - 03:00 pm
60 Minutes Per Day
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)
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)
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)
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)
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)
Reduce Risk! Control Costs! Get to Market Faster! The Customer Solution Centre is Your Pathway to Successful Device Development.
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
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)
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)
Understanding adhesion issues is crucial for medical device manufacturers – but it’s also a commonly overlooked factor. Adhesion of a coating to its target surface is a critical element that can dramatically affect medical device performance. Lacking adequate adhesion can cause a variety of problems including delamination, corrosion, electrical failure, and more. In order to have a successful medical device, manufacturers must avoid these complications by understanding and responding to adhesion issues that can arise in a medical device.
Wed, Sep 28, 2016 - 02:00 pm - 03:00 pm
This webinar will address the details surrounding the new ISO 80369 standards that are affecting medical device manufacturers. The expert in this webinar will outline what ISO 80369 standards are, how they will affect the industry, and when the standards will come into effect.
Mon, Sep 12, 2016 (All day)
Automation is becoming a key component of the industry and should be a heavily weighted factor in selecting vendor partners. Whether utilizing a highly automated cell complete with 8-axis robots and vision inspection capabilities, or a simple solution through fixturing or palletization, automation provides the following key benefits: higher throughput, higher utilization rates, reduction in labor costs, reduction of opportunity costs and process repeatability and consistency.
Tue, Sep 6, 2016 (All day) - Wed, Sep 6, 2017 (All day)
This three day course will incorporate the new US FDA guidance on biocompatibility into the three main steps in developing a Biological Safety Evaluation (BSE): Biological Evaluation Plan (BEP), Testing Options, and Biological Evaluation Report (BER). Composed of three one-hour presentations followed by Q&A sessions, the course will cover each step in developing a BSE in detail. This course will provide insight into regulatory expectations when it comes to evaluating device safety.
Tue, Aug 30, 2016 - 02:00 pm - Thu, Sep 1, 2016 - 03:00 pm
60-mins per day
- Drowning in Big Data: Extracting Medical Device Quality and Safety Insights - Webcast
- Quality with Confidence – What You Need to Know About Digital Microscopes for Medical Device Quality Processes - Webcast
- Risk Management for Medical Device Manufacturers - Webcast
- 3 Steps for Designing the Ideal Medical Device Packaging System - Webcast
- Reducing Device Cost with Innovative Medical Materials - Webcast
- Automating your Quality Management System: Pitfalls & Essentials - Webcast