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Event Details
Wednesday, February 1st – Noon - 1:30pm
Lane Powell PC – Mt. Baker Conference Room
1420 Fifth Avenue, Suite 4200
Seattle, WA 98101
Academy Topic: Protect your Medtech investment - Better understand the regulatory process of medical technology.
About the Topic: In this lecture, you will learn the regulatory affairs process of a medical device and why it is so important to a company's future and growth. You will come to realize what is different between regulatory policies in various markets and what actions should be taken into consideration when planning on entering new markets.
You will be able to answer important questions such as;
What is easier - US FDA or CE mark in Europe? Which approval had more value in the global plan? When is it necessary to provide clinical data to achieve any market access ? Can I start selling in other countries first before I obtain my domestic market approval? Is there a benefit in obtaining market clearances while product efficacy and user acceptance are underway? How can I use my product' approval portfolio to increase my investment evaluation ? You will observe how leading regulatory affairs professionals are managing effectively multiple products registration processes in many countries in real-time and in control. Recognize the change in the role of the regulatory affairs departments within the organization as they are now capable, to obtain market access in advance, independently from a distributors or third party consultant. All in line with the latest most updated device specific intelligence in each market.
SPEAKER BIO Benjamin Arazy is the CEO and founder of the Arazy Group Consultant Inc. the company behind Licensale.com, a cloud-based solution that transforms the approval process of medical technology for sales and obtains global markets access. Leveraging on 20 years of involvement with the MedTech industry, international operations and advance medical technology and applications, Benny and his firm takes pride in being instrumental in making thousands of medical devices accessible to physician and patients worldwide.
Parking: Parking is available in the U.S. Bank Centre.
We look forward to your attendance and participation!
The Keiretsu Forum Northwest Team
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Questions? Please call 206-529-3687
When
Location
- U.S. Bank Centre, 1420 5th Ave #4200, Seattle, WA 98101, USA