March 11, 2013 – Irvine, CA
While the exploding medical device market offers growth opportunities, it demands safety along innovation from the technology providers. Learning key requirements of the FDA 510K clearance process and the newly added “Human Factors” to deliver quality products on time is critical to your success as a developer. Get the updates!
In this intense single-day training event experts will share their expertise and years of experience to help you streamline the FDA process and minimize risks to stay competitive in your product development. You will also learn essential information such as new changes of IEC 60601-1 3rd edition (ES 60601-1), IEC 62304 and ISO 14971 in medical device development designed just for you. As an added bonus, you will gain insight on the medical devices design and validation process (both software and hardware) which will help you get a head start.
This event is $295, if you have a promo code please enter it on the registration page.
Exhibitors:
Gold:
Silver:
Standard:
You can also register by phone:
Jasmine Formanek
Event Sales
jasminef@rtcgroup.com
(949) 226-2004
WHAT YOU WILL LEARN?
In this MEDS training event, you will learn:
- Learn about the updated FDA 510K clearance process
- How you can be prepared for the application process
- Understanding the FDA authority and inspection
- Prepare for the audit
- How to streaming the process
- Understanding the Human Factor impact
- Learn the new changes of IEC 60601-1 3rd edition (ES 60601-1), IEC 62304 and ISO 14971 and their impact on your design process
- Learn the medical device design and validation process for software and software; how to speed up the design process
- Case studies from leading health organizations
WHAT YOU WILL GET?
- A training certificate
- Training binder
- Refreshments, lunch & after hours networking reception
- Discounts on future training events
WHO SHOULD ATTEND?
- Medical device developers and engineers
- Software developers and engineers
- Project engineers
- Hardware device project managers
- Software project managers
- Validation engineers
- R&D and product development
- QA/QC team members
- Test engineers
- Compliance and regulatory/ legislative affairs professionals
- Risk management specialists
- Manufacturing engineers
- Service providers
- Designed for both large medical device manufacturers and start-ups
AGENDA
| Start | End | Topics | |
| 7:00A | 8:00A | Set-up/Rehearsal – Speakers and Sponsors – all sponsors must be ready when the doors open at 8:00AM | |
| 8:00A | 9:00A | Registration & Refreshments – Exhibit Hall Open | |
| 9:00A | 9:15A | Welcome and Introduction | |
| 9:15A | 10:15A | Speaking Session 1 – More info | Meeting Software Safety Requirements for Medical Devices: Review of IEC 60601-1 and IEC 62304. (Presented by UL) |
| 10:15A | 11:15A | Speaking Session 2 – More info | Streamlining the FDA Clearance Process in all classes and stop wasting time (Presented by Bentley Biomedical Consulting) |
| 11:15A | 11:30A | Break | |
| 11:30A | 12:30P | Speaking Session 3 – More info | The FDA and Human Factors: Now Human Factors Testing is an FDA Requirement (Presented by Medical Device Human Factors by HirLan) |
| 12:30P | 1:45P | Lunch and Networking – Exhibit Hall | |
| 1:45P | 2:00P | Solution Provider Sessions presented by Visure Solutions | |
| 2:00P | 3:00P | Speaking Session 4 – More info | The secret of designing safe yet innovative medical devices (Presented by LogicPD) |
| 3:00p | 3:15p | Break | |
| 3:15P | 3:45P | Speaking Session 5 – More info | What is ISO 13485—How Important Is It? |
| 3:45P | 4:30P | Solution Provider Sessions presented by LDRA, Vector Software, & Wind River |
|
| 4:30P | 6:00P | Networking and Reception – Exhibit Hall Open | |
LOCATION:
Brandman College Irvine Campus
16355 Laguna Canyon Road
Irvine, CA 92618
