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
Launching a medical device is easy as 1-2-3. Right? Well, it’s not exactly that easy. There are key items you’ll want to consider for successfully launching an outsourced medical device, on-time and within budget. This webinar will identify how to select the right contract manufacturer to ensure the success of your device launch, explain why it is crucial to start planning the device packaging early in the design process, and outline the steps necessary to keep your product launch on schedule and on budget. If you are part of a design or new product team, you won’t want to miss it!
Wed, Jul 27, 2016 - 11:00 am - Thu, Jul 27, 2017 - 11:00 am
One of the first questions that comes to mind after completing an EO sterilization qualification is, "When do I need to perform a requalification study, and what will that study entail?" Maintaining the validated state of a sterilization cycle and ensuring the process consistently and continually delivers the desired SAL is of utmost importance. This presentation takes a comprehensive look at the typical validation approach, the factors that determine when requalification is necessary, and how the expectations in ANSI/AAMI/ISO 11135 have changed in recent years regarding requalification.
Thu, Jul 21, 2016 (All day)
Learn how rapid prototyping enabled by digital manufacturing can help you shave weeks or even months off the medical device development process. We will explain how utilizing process such as 3-D printing, CNC machining, and low-volume manufacturing, you can reduce manufacturing costs, decrease prototyping lead times, minimize risks, and beat the competition to market.
Wed, Jun 22, 2016 - 11:00 am - Thu, Jun 22, 2017 - 11:00 am
Literature research and chemical characterization tests are increasingly becoming alternatives when it comes to reducing biocompatibility testing on animals. In fact, considerable progress is being made in the development and standardization of new in vitro test methods—particularly when it comes to cytotoxicity, sensitization, and irritation, the basic tests performed for any medical device regardless of the device's application. These alternative in vitro methods provide multiple benefits, including a smaller sample amount, less time required to perform the test, and reduced animal use.
Thu, May 19, 2016 (All day) - Fri, May 19, 2017 (All day)
In the competitive landscape of medical devices and the advantages to being first to the market, many are tempted to move into product development at a rapid pace. Moving into product development quickly is full of risks, particularly in the medical technology space where development is heavily regulated and process driven. There are several elements of product development that you must thoroughly understand prior to entering formal medical device development to reduce risk. Do you know what regulatory path is most appropriate? Are you certain of your Freedom to Operate? Will your funding be sufficient to get you to the finish line? Missteps will certainly cost you time and money and might even doom your product altogether. Join us for a webinar that will outline five things that are crucial to the success of your product development effort. We will also look at the implications of moving into formal device development too soon and methods for assessing risk.
Wed, Apr 27, 2016 - 11:00 am - Thu, Apr 27, 2017 - 11:00 am
This course will discuss the foundations of risk and the application of risk management to medical devices before and after market launch. Composed of three one-hour lectures followed by Q&A sessions, the course will cover the evolution of our modern concept of risk and will provide practical guidance on how to minimize risk throughout the product development cycle. The class also will provide a basic introduction to risk management and inductive and deductive risk analysis tools.
Tue, Apr 19, 2016 (All day) - Thu, Apr 21, 2016 (All day)
60-minutes per day
Conceptualizing, developing and bringing a medical device to market can be punctuated with setbacks. This webinar will help you identify and avoid potential issues at every stage during the product development process. Learn about the benefits of using a known signal, range of test devices that can help you meet regulatory requirements, and how to accurately measure physiological parameters.
Thu, Mar 31, 2016 (All day)
This is a practical crash course on 21 CFR 820 and EN ISO 13485:2012, as well as the key focal points for each element and subpart. Whether you're a startup building a Quality Management System (QMS) for the first time or a Fortune 100 medtech company looking for specific help in a QMS area, learn insider tricks from St. Cloud State University Adjunct Professor and top 40 Under 40 consultant David Amor, an expert who has led multiple QMS implementation and remediation projects for large companies and startups alike. This course focuses on the stuff you can't Google and will take a boot-camp approach to implementing and solving many common QMS obstacles.
Tue, Mar 15, 2016 - 02:00 pm - Thu, Mar 17, 2016 - 03:00 pm
60-minutes per day
Water is one of the most widely used raw materials in the MedTech industry; yet water systems are often overlooked as a source of contamination. Register for this webinar to learn the effects water impurities can have and how to select quality water attributes for processes, system qualification, monitoring, and process controls. Attendees will also gain insight into recovering existing water systems, and proper design for new water systems.
Tue, Nov 10, 2015 (All day)
Currently there is an initiative in the ISO technical committee on sterilization of healthcare products to develop a standard which discusses assurance of sterility. As the content for the ISO standard is developed to represent current and future industry thinking worldwide, several topics have been discussed in detail which we’ll review in this webinar.
Tue, Sep 22, 2015 (All day)
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
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
- Considerations for Third-Party Reprocessing Of Single-Use Medical Devices - Webcast
- 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