Most companies create an IFU for a new product by plagiarism. They merely copy a competitor’s IFU and change the name. If the IFU is created by a regulatory expert, the IFU will be nearly identical to the competitor IFU. However, if the IFU is created by a marketing person, the IFU will explain how your product is total different from the competitor product. Neither approach is effective. In the current regulatory environment you must use a risk-based approach, perform IFU validation and monitor post-market surveillance to determine if your IFU needs to be changed. In this webinar you will learn:
- How to develop your IFU using a risk-based approach
- Methods for IFU validation
- New Tools for gathering post-market surveillance and PMCF data
- How to revise and revalidate your IFU
What you will receive for $49
- access to the live webinar (new Zoom platform)
- a recording of the webinar you can replay anytime (mp4 format)
- the most recent version of my template for a Draft IFU (Word doc)
- the native slide deck for this webinar (PPT format)
There will be 25-35 slides during the presentation. The presentation will be 45-50 minutes in duration, and you will have the opportunity to ask questions during the live webinar. Content will be sent via AWeber emails to confirmed subscribers.
IFU Validation Webinar ($49)
In this webinar you will learn how to validate your IFU prior to commercialization and how to conduct post-market surveillance (PMS) to ensure that your instructions for use continue to be suitable as your user population and patient population expand.
When is the IFU Validation Webinar?
On Friday, April 21 we will be hosting the IFU Validation Webinar live at 11:00am EDT.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.