BSI - making exellence a habit
2014
Roadshow

The 2014 Medical Device Roadshow

Managing Today's European Regulatory and Compliance Expectations While Preparing for Changes in the Future.
Register today !

Mon, Sep 8, 2014
Biltmore Hotel & Suites
2151 Laurelwood Rd.
Santa Clara, CA 95054

Wed, Sep 10, 2014
Radisson Newport Beach
4545 MacArthur Blvd.
Newport Beach, CA 92660

Fri, Sep 12, 2014
Boston Marriott Burlington
One Burlington Mall Rd.
Burlington, MA 01803

Mon, Sep 15, 2014
Minneapolis Marriott West
9960 Wayzata Blvd.
Minneapolis, MN 55426

Changing Regulatory Requirements and the Impact on Achieving and Maintaining CE Marking

BSI is proud to host our third annual EU Medical Devices Regulatory Roadshow for the medical device community. Our exclusive one-day Roadshow will bring you to the forefront of current expectations, the likely timetable of changes, and experience gained from unannounced audits. We invite you to join our global panel of experts to discuss critical topics and receive valuable insights from the leading Notified Body, ISO 13485 registrar and first national standards body.

Please join us in the city nearest you:

Mon, Sep 8, 2014
Santa Clara, CA Details

hotel website
get directions

Wed, Sep 10, 2014
Newport Beach, CA Details

hotel website
get directions

Fri, Sep 12, 2014
Burlington, MA Details

hotel website
get directions

Mon, Sep 15, 2014
Minneapolis, MN Details

hotel website
get directions

Spread the Word

The regulatory road is full of twists and turns. We'll help you stay on course.

  • "This was a wonderful event, and is continued evidence the BSI is an excellent Notified Body."
  • "This course offered a great deal of valuable information."
  • "I liked the casualness of the presentation and the 'no pressure' approach to disseminating this critical information. It was a great day to get to know BSI."
  • "Just perfect!!!"
  • "Impressed with conference and resource of BSI for regulatory updates."
  • "Event was very well organized with great topics at the perfect time."
  • "An excellent event! Well organized and the topic on current and upcoming changes were well presented and timely. Thank you!"
  • "I enjoyed the event and learned a great deal. It was very balanced - gave good overview and went into more detail on recent changes and also was great in guessing future trends."

About BSI

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.

The Support of an Industry-Leading Medical Device Team

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.

Expertly Driven Partnerships

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.

http://medicaldevices.bsigroup.com

The Support of an Industry-Leading Team

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.

Event Speakers and Representatives

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).

Bill Enos, Microbiology Team Leader, has been with BSI for 10 years. His responsibilities include auditing quality systems and review of design dossiers/technical files and other certification activities related to sterile medical devices (environmental controls, sterilization validation and release, biocompatibility, accelerated aging, package validations, tissues of animal origin, etc). He has developed training programs on biocompatibility testing, devices containing tissues of animal origin, and sterilization activities.

Bill received his bachelor of science degree in microbiology in 1993 from Western New England University. Bill is the co-author of the book "Revisions to the Ethylene Oxide & Radiation Sterilization Standards – Gap Analysis (2009)".

Sue Spencer, Head of IVD, has 26 years of experience in the IVD industry, and has held various positions in research and development, manufacturing, and quality assurance. Sue has developed BSI’s IVD program to deliver a full scope Notified Body that provides a world-wide service to clients. Her expertise spans both the Medical Device and IVD Directive during the introduction of both the Medical Device and IVD Directives.

Stefan Burde, IVD Product Expert, in the In Vitro Diagnostics Notified Body at BSI Healthcare. Dr. Burde has over 13 years of experience in the In Vitro Diagnostics Industry in the development and manufacturing of IVDs for US, European and global markets. His prior positions include Bayer Biological Products, bioMérieux, and Advanced Liquid Logic, as well as independent consulting work for IVD start-ups.

He joined BSI in 2014 as part of BSI’s expansion of the IVD team to address the growing need for Quality and Technical assessments by the IVD Notified Body in response to the upcoming changes to the European In Vitro Diagnostics Regulation.

Greg Martin, Product Expert and Technical Reviewer for Active Implantable Team, has over 13 years of experience conducting research, development, and project management for pacemakers and implantable neurostimulators. Mr. Martin has extensive experience in the design of software and electronics for implants and their accessories.

In addition to reviewing medical device submissions for CE marking, Mr. Martin trains QMS assessors on auditing software lifecycle development processes and leads BSI’s Software Healthcare Working Group.

Itoro Udofia, Global Head - Ortho & Dental Devices, has a background in academia and research, consultancy and working with leading orthopaedic manufacturers in the research and development of their products. Itoro is the Global Head of the Orthopaedic and Dental Medical Devices team at BSI, leading a team of product experts that are responsible for all aspects of CE marking and ISO 13485 for more than 200 clients globally

Itoro has over 14 years working experience with orthopaedics devices, including five years in for a Notified Body.

Laurel Macomber, MS, PMP, RAC, Product Expert, has over 25 years of experience in medical device manufacturing including research and development, program management, and quality systems. Her expertise spans across Orthopaedic, Neurosurgical, Cardiovascular, and Spinal products. Her professional experience includes numerous engineering positions and Director, Program Management Office.

Dates and Locations

2151 Laurelwood Rd. Santa Clara, CA 95054

Mon, Sep 8, 2014

Biltmore Hotel & Suites

2151 Laurelwood Rd.
Santa Clara, CA 95054
United States
800.255.9925
4545 MacArthur Blvd. Newport Beach, CA 92660

Wed, Sep 10, 2014

Radisson Newport Beach

4545 MacArthur Blvd.
Newport Beach, CA 92660
United States
800.967.9033
One Burlington Mall Rd. Burlington, MA 01803

Fri, Sep 12, 2014

Boston Marriott Burlington

One Burlington Mall Rd.
Burlington, MA 01803
United States
781.229.6565
9960 Wayzata Blvd. Minneapolis, MN 55426

Mon, Sep 15, 2014

Minneapolis Marriott West

9960 Wayzata Blvd.
Minneapolis, MN 55426
United States
952.544.4400

Topics

7:30 am – 8:30 am

Registration

8:30 am - 4:30 pm

Meeting

Event Topics

  • The new ISO 13485 – Will You Be Ready?
  • EU Regulatory Update
  • Clinical data evaluation – a holistic approach to Risk management
  • Post production phase common non-compliances
  • Key pit falls to avoid in preparing technical documentation
  • Unannounced Visit Experience

IVD Sessions available in San Jose, Irvine, and Boston only

  • What you need to know about the new European IVD Regulation
  • Transitioning between the IVD Directive and the IVD Regulation
Registration
© 2014 BSI Group America Inc.BSI Home Contact 1.888.429.6178