NAMSA MRO Summit - Israel: Gain Proven Strategies & Resources for Successful Medical Device Development
NAMSA’s MRO Summits bring thought leadership and industry experts directly to you. These complimentary, intimate gatherings provide presentations and panel conversations devoted to real-world case studies and proven strategies that are key to efficient medical device development. Following your participation in this unique, day-long event, you will leave with recommendations, guidance and resources required to successfully navigate the product development and market approval pathways.
MRO Summit: Keisarya, Israel
Date: Wednesday, September 13, 2017 (9:00 AM - 4:00 PM IST)
Location: Dan Caesarea Hotel
(Registration will begin at 9:00 AM IST with event kick-off at 10:00 AM;
lunch will be provided).
Using Material and Chemical Characterization for Biological Safety
Learn what types of material and test data are most useful when evaluating medical devices. How can you use data to properly minimize unnecessary testing as outlined in ISO 10993-1 and the FDA Guidance? How does ISO 10993-18 and chemistry testing data relate to biological safety evaluations? This session will not only discuss how vendor data can be valuable when used properly, but also how performing chemistry testing could lessen the biological test burden.
Global Regulatory Pathways: Plan For Successful Submissions
Learn how to avoid common regulatory mistakes and helpful tips of the trade for international medical device submissions. Discussion will also include how to master the market clearance process without becoming victim to common pitfalls.
Strategic Clinical Research: How to Get the Most Out of Your Data
Clinical research is a critical component of medical device development occurring throughout the product development continuum. Learn what clinical research can help best guide specific product designs, and how different types of clinical research and clinical evidence may be able to support market penetration and market expansion.
Who Should Attend
- Clinical Affairs Specialist, Manager or Director
- Product Development
- Research & Development
- Regulatory Affairs Specialist, Manager or Director
- Quality Assurance Specialist, Manager or Director
- Clinical Operations
- Clinical Project Management
- Design Engineers
- Marketing Manager or Director
What is an MRO?
NAMSA is the first and only Medical Research Organization (MRO) in the world. Driven by our regulatory expertise, the NAMSA MRO® Approach plays an important role in translational research, and applies a unique combination of disciplines — consulting, preclinical, toxicology, microbiology, chemistry, clinical and quality — to efficiently move clients' products through the development process, and provide support through commercialization to post-market requirements, anywhere in the world.