September 20, 2012, Rob Long
Do you ever wonder which aspects of a 510(k) submission the FDA scrutinizes the most? Or what the likelihood is of becoming involved in litigation after product launch? Maybe you just want to know: “How do I go about testing my spinal device?” Accutek answers all of these questions, and more, at our inaugural “Lunch & Learn”.
Our event is independent from the official program as planned by the NASS Annual Meeting Program Committee.
Accutek is pleased to extend this invitation to all spinal device designers, manufacturers, or other interested parties.
“Avoiding Pitfalls: Regulatory, Mechanical Testing, and Legal Considerations when Bringing a Spinal Device to Market”
Date: October 25, 2012
Time: 11:30 a.m.
Location: Omni Hotel - Downtown Dallas
Accutek’s “Lunch & Learn” features a full slate of industry professionals offering their insight on a variety of spinal device topics.
Speaker Agenda
• “How Can Accutek Help?” John McCloy, President of Accutek, will provide a general overview and background information regarding Accutek’s unique capabilities.
• “What Does the FDA Look For?” Get answers to your burning questions about the FDA and their submission process from former FDA Orthopedic Device Branch Manager, Glenn Stiegman. Mr. Stiegman , VP of Clinical & Regulatory Affairs at MCRA, has authored several FDA Guidance Documents for Spinal Devices and has reviewed numerous spinal submissions during his tenure at the FDA. He will provide unique insights into the FDA and what they look for in 510(k) submissions from start-up and mid-range spinal companies.
• “How Do I Test My Device?” Accutek Senior Project Engineer Maciej Jakucki will speak about the questions and concerns that he sees on a regular basis from individuals with spinal devices to test. Mr. Jakucki will also provide an overview of test methods for various spinal devices.
• “The Essential Discovery Tools for Defending Medical Device Litigation” As Partner & Chair of Healthcare at SmithAmundsen, Carmel Cosgrave has seen her fair share of litigation involving spinal device manufacturers. Ms. Cosgrave will discuss how likely litigation is for a small spinal company, common pitfalls that lead to litigation, and how to plan ahead now to avoid litigation in the future.
To register online, view speaker bios, or learn more about our event, visit the event page.
Any additional questions may be directed to Rob Long at 513-984-4112 x1230 or email at rlong@accutektesting.com
See you in Dallas!
P.S. Don’t forget to visit Accutek at: NASS Annual Meeting - Booth #513 - October 24-27, 2012.
