Recalls and other field actions are unavoidable in the medical device industry. How manufacturers evaluate risks and manage recalls makes a significant difference in public safety and a company’s reputation and bottom line. This conference offers a unique opportunity to hear and interact with key FDA and industry experts on the thought processes, procedures, and practical issues involved in medical device recalls.
Recorded May 17-19, 2017, The fifth annual MedTech Intelligence medical device recalls conference featured senior level CDRH and industry speakers for in-depth discussions of a range of new topics, including new FDA initiatives, the practical application of benefit-risk to recalls, the use of decision analysis, the Risk Assessment Form, clinical versus engineering perspectives on risk, procedures and expectations for recall termination, and hospital recommendations for more effective recall communications and processes. Price: $1,495
Recorded: December 13, 2016. The key becomes one of risk-based thinking in supply chain quality. In this webinar, we will look at the various elements that focus on the ability to connect with the supply chain, while maintaining an acceptable level of regulatory compliance. Sponsored by Verse Solutions.
Recorded March 23-24, 2017 – Medical device cybersecurity is a looming threat that often appears in the news. Unlike most cybersecurity programs that merely raise the dreaded spectre of what may go wrong, this highly interactive workshop focuses on practical steps that manufacturers can take. How can you design and test secure products, monitor safeguards for effectiveness, and what emergency procedures should be in place to minimize damage and liability in the event of a breach? Price $995.00
Recorded: March 21 & 22, 2017 – Software is ubiquitous in the world of medical technology, and is the source of many problems and enforcement actions. For the regulatory, quality, and product development professionals who manage and oversee software inside of or connecting their products, it can be difficult to interact most productively with IT professionals. This interactive workshop is specifically designed to help non-software professionals better understand what to look for and beware of, what questions to ask and decisions to make, and how to monitor products and systems for potential issues. Price: $995.00
Recorded March 1-2, 2017 – “Going to panel” can make or break a new technology or company. An FDA Advisory Committee meeting is the culmination of much time, effort, and money. The outcome can determine whether a product makes its way to market or not. Knowing the procedures, learning from past experience, and understanding the participants and attendees and their roles, biases, and objectives are all critically important in helping a company most effectively prepare the most persuasive case while providing for possible contingencies. In this unique workshop, experienced professionals share experiences and best practices for preparing for and conducting a medical device panel meeting. Price $995.00
This program brings together government, industry, and other experts to discuss the challenges of Production and Process Validation and Test Method Validation and practical approaches to meeting them. Recorded February 2017. Price: $995.00
Product development is the key to a vital and profitable medical technology industry, but the process poses many challenges, according to a recent reader survey conducted by MedTech Intelligence. This webinar features industry experts in a roundtable discussion addressing key issues in product development. Recorded June 9, 2016.