Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073
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Half-Day Medical Device Special Meeting
Registration is closed
Registration cancellations will be accepted until Thursday, January 12, 2017 at 7:00 PM
TOPIC: Half-Day Medical Device Special Meeting
DESCRIPTION AND SCHEDULE
We understand the specific challenges facing US medical device manufacturers and the importance of bringing innovative yet safe products to American and global markets. Ensuring the predictability and transparency of regulatory product clearance is key to maintaining a competitive edge.
The challenges medical device manufacturers face in today’s highly competitive marketplace make it essential to ensure that your product meets all regulatory and quality requirements before launch. It is critical to work with a leader who understands the industry and has the experience to review and confirm the products’ readiness for market – efficiently, reliably and promptly. BSI is a company that has been leading the way in assisting manufacturers to navigate through the maze of regulatory requirements.
BSI a respected, world-class Notified Body dedicated to providing rigorous regulatory and quality management reviews and product certifications for medical device manufacturers — around the world. For more than 100 years, BSI’s expertise has provided an assurance of safety and quality to manufacturers in over 150 countries.
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7:30-8:00am
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Registration & Breakfast
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8:00-8:15am
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Welcome & Introduction
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8:15-9:15am
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Medical Device Regulation (Dr. Ibim Tariah)
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9:15-9:30am
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Own Brand Labeling/Virtual Manufacturer (John Bis)
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9:30-10:00
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MEDDEV 2.7.1 Rev 4 – BSI approach (Dr. Ronald Rakos)
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10:00-10:15am
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Break
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10:15-11:00am
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Designing Compliant/Risk Appropriate Post Market Surveillance and PMCF (Dr. Ibim Tariah)
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11:00-11:45am
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MDSAP – medical device single audit program (Tony Rizzo)
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11:45-12:00pm
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Closing Remarks
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12:00pm-1:00pm
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Optional: Networking
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SPEAKERS: Dr. Ibim Tariah, John Bis, Dr. Ronald Rakos, Tony Rizzo
SPEAKERS BIOGRAPHIES
Ibim Tariah - Dr. Tariah has over 24 years of experience in the medical device industry leading global organizations in successful product development, project management and product expertise. Dr. Tariah has been providing expertise in Vascular, Orthopaedic and Dental, and other long-term implantable devices for clients needing technical documentation assessment and reviews. His vast experience includes regulatory knowledge of combination devices incorporating biologics, drugs and drug-biologics. He also acts as a liaison with Regulatory Authorities including MHRA, European Medicines Agency (EMA), Medical Products Agency (Sweden), FDA, Health Canada and Therapeutic Goods Administration (TGA).
John Bis, Vice President Healthcare Solutions, with over 21 years of experience in the Healthcare industry. John collaborates with professionals and organizations who serve the medical industry worldwide. John is driven to ensure BSI clients are provided quality services that include but are not limited to: Assessments, CE Marking, Business Management Software Tools, Training, Resource Tools and Technical Expertise that ensure that their clients succeed in regard to bringing quality products to the healthcare market. John leads a highly talented team of account managers who help their clients achieve excellence in the healthcare market.
Ronald Rakos, Ph.D., MBA, RAC; BSI, Global Head, Vascular Medical Devices. Ronald Rakos joined BSI in 2007 and has a has held a number of positions in the organization from Product Specialists to his current role as Global Head for the Vascular Medical Devices team that is composed of twenty vascular product specialists that are located around the world. This allows Ron and his team of experts to service clients globally. He has spent over 12 years working in the medical technology industry; 2 years in Manufacturing Engineering and 10 years in Research and Development. Prior to entering the medical device field he performed computational modeling of polymer processing operations.
Tony Rizzo, AVP Healthcare Business Development, BSI, has been with BSI for 12 years and is currently the AVP of Healthcare Business Development for BSI. Prior to joining BSI he spent 24 years in the Quality industry, 6 of those years as a consultant focusing on Quality Management Systems for international companies in the area of automotive and medical devices. He also served 8 years as president of a testing and technical services organization in Japan and 10 years in other senior management and operational positions at an inspection, testing, and surveillance organization. Tony holds an MS from MIT.
WHO: Clinical, regulatory, quality, manufacturing and legal
This meeting includes:
- Continental breakfast
- Coffee and tea for the remainder of the meeting
Attendance at this meeting may be applied as 3 points towards RAC re-certification
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