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
Companies looking to deliver IoT solutions need the ability to deliver new value added features and services continuously to their customers without compromising product quality. ALM & Virtual Labs improve two key areas for product quality: collaboration between developers in different departments, and automation of development tasks. Attendees will learn why maximizing team collaboration throughout the entire development project is key when speeding up delivery times, how automating processes in test and build management can be achieved with increased traceability, and how operating costs are reduced.
Tue, Feb 16, 2016 - 11:00 am - 12:00 pm
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
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
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
- Reducing Device Cost with Innovative Medical Materials - Webcast
- Automating your Quality Management System: Pitfalls & Essentials - Webcast
- 3D Printing for Surgical Devices and Medical Models - Webcast
- The Power of Extractable/Leachable Chemistry Testing for Medical Devices - Webcast
- Changing a Colorant in an Approved Medical Device, What Should I Know? - Webcast
- Reduce Risk! Control Costs! Get to Market Faster! The Customer Solution Centre is Your Pathway to Successful Device Development. - Webcast