UL’s Experts Forum
On Thursday, January 14th, UL’s Experts Forum event will provide a chance for you and your team to participate in technical discussions and one-on-one meetings with UL’s Health Sciences technical experts. The morning seminar topics will be focused on IEC 6061-1, 3rd Ed. changes, Human Factors Engineering, IEC 6061-1 Certification and China Access, upcoming ISO 13485 changes, new IVD regulation in Europe and Cybersecurity. Following the morning presentations a limited number of 30 min 1:1 meetings with the UL experts will be available. Be sure to reserve your meeting when registering for this event.
Times, topics and speakers:
8:00 – 8:25 – Registration
8:25- 8:30 – Introductions – Anja Crotts, Senior Account Manager
8:30- 12:30- Expert Presentations- topics and summaries below (Lunch will be provided during this time as well)
- Amendment 1 of IEC 60601-1, 3rd Ed – What are the changes? Amendment 1 of IEC 606061-1, 3rd Edition made changes that can benefit manufacturers looking to show compliance to in their medical electrical equipment. However, some of the changes can have a bigger impact on the compliance process. We will discuss the major changes in the standard along with changes made to the CB Scheme Certification Process based on using the standard.
- Human Factors Engineering We will discuss why applying Human Factors Engineering (HFE) is crucial to ensuring a medical device’s safety and usability. We will also cover the HFE-specific regulatory requirements and how HFE fits into the overall product development process.
- Rethinking the IEC 60601-1 Certification Process and China access – As the IEC 60601-1 medical series of standards continues to evolve and devices are becoming more complicated, the role of the manufacturer in the certification process becomes more challenging. We will discuss different approaches we’ve seen and things to consider making the process more efficient and effective for all parties involved. Additionally, we discuss an option with regards to safety testing for the CFDA process and a new way to get into China!
- ISO 13485 – Change is in the air. We will explore what the changes to ISO 13485 are, as well as what is coming. We will discuss how companies can implement those changes into their processes to ensure success.
- New IVD Regulation – The IVD directive will be changed into a regulation in Europe. What does this mean, and what does an IVD company need to do to prepare?
- An Introduction to UL’s Cybersecurity Assurance Program – We will present UL’s Cybersecurity Assurance Program, providing an overview of the program and its anticipated requirements that are currently being development. We will also provide information as to how they may participate in our pilot program currently underway.
12:30 – 1:00 PM - Break
1:00 – 5:00 PM, one-on-one 30 min. sessions (Available appointment times can be found by clicking the registration link above.)
Cost: 1st Registration $68, Each Additional Registration $58 *Use the Coupon Code "EXPERT" for additional registration discount.
When: Thursday, January 14, 2016– 8:00 – 5:00 PM Location: Stradling Yocca Carlson & Rauth, 4365 Executive Dr., Suite 1500, San Diego, CA 92121
For more information on this event contact Anja Crotts at [email protected]