Managing Today's European Regulatory and Compliance Expectations While Preparing for Changes in the Future.
The Roadshow is FREE to attend. Register today !
Tues, Mar 10, 2015
Hilton St. Petersburg Carillon Park
950 Lake Carillon Dr.
Saint Petersburg, FL 33716
Thurs, Mar 12, 2015
Marriott Memphis East
5795 Poplar Ave.
Memphis, TN 38119
Tues, Apr 14, 2015
Hyatt House Boulder / Broomfield
13351 W. Midway Blvd.
Broomfield, CO 80020
Thurs, Apr 16, 2015
Chicago Marriott Naperville
1801 N. Naper Blvd.
Naperville, IL 60563
BSI is pleased to be supporting the medical device manufacturer regulatory affairs and quality assurance professionals by offering the opportunity to attend our second annual Mini-Roadshow program. Our exclusive half-day Roadshow program will provide the latest update on topical changes proposed on European medical device regulations, ISO 13485, MDSAP and Unannounced Visit experience. Key technical sessions will also review current expectations and best practices for CE Marking clinical data evaluation and common problems with technical documentation supporting compliance with EU medical devices directives. Also showcased during the morning will be an innovative new solution for managing and maintaining awareness of the latest draft/published standards to support medical device compliance and an effective tool for managing QMS actions. We invite you join the BSI experts to discuss critical topics and receive valuable timely insights from the perspective of the leading North American CE Marking medical device Notified Body, ISO 13485 registrar and the first national standards body.
Please join us in the city nearest you:
The regulatory road is full of twists and turns. We'll help you stay on course.
BSI is the world’s first national standards body partnering with medical device manufacturers to provide impartial third-party standards based assurance, compliance, information solutions, and training. Backed by 80,000 client locations in over 100 countries, and more than 50 BSI offices, we are the trusted partner of Industry and Government professionals all over the world.
BSI is an approved "full scope" Notified Body, recognized by the European Commission for 17 directives and by the FDA, CMDCAS, JPAL, LG/ZLS, and TGA. Every day, we work with our customers to deliver on our global mission: To ensure patient safety while supporting timely access to medical device technology.
Our Medical Device team is made up of more than 200 global experts in medical technology. Our team members have an average of 20 years of industry and regulatory experience—many of them holding patents in their respective fields. With experience in Class I-IV devices, our team can offer your organization a total solution to navigate the regulatory pathways and demonstrate continued compliance.
BSI combines an expert understanding of local and regional medical device regulatory issues with the efficiency and cost-effectiveness of a global network of industry resources. By partnering with BSI, our customers can count on more than just technical capabilities and testing capacity. We build long-term working relationships to identify challenges and create solutions that meet each customer’s unique needs.
Our Medical Device team is made up of more than 200 global experts in medical technology. Our team members have an average of 20 years of industry and regulatory experience – many of them holding patents in their respective fields. With experience in Class I-IV devices, our team can offer your organization a total solution to navigate the regulatory pathways and demonstrate continued compliance.
Paul Brooks, Senior Vice President Healthcare Solutions, leads the Healthcare sector in the Americas for BSI. Paul was the Head of the Notified Body for BSI's Medical Devices Group from 1998 to 2002 during which time he represented BSI at meetings in Brussels with the European Commission.
Mr. Brooks is responsible for leading BSI’s medical device business in the Americas, including CE Marking Programs and interfacing with U.S. FDA and Health Canada.
Paul is a long standing member of the American Society for Quality Biomedical Division and currently Chairman of the Board of Regulatory Affairs Professional Society (RAPS).
Dr. Ibim Tariah, Technical Director, has over 24 years 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, has over 21 years of experience in the Healthcare industry. John collaborates with professionals and organizations who serve the medical industry world-wide.
John is driven to ensure BSI clients are provided quality services that include but not limited to; Assessments, CE Marking, Business Management Software Tools, Training, Resource Tools and Technical Expertise that ensure that our clients succeed in regard to bringing quality products to the healthcare market. John leads a highly talented team of account managers who help our clients achieve excellence in the healthcare market.
Registration and Breakfast