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2014
Mini-Roadshow

Mapping Your Success

The 2014 Medical Device Mini-Roadshow

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

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

BSI is proud to host our first mini-roadshow for the medical device community. Our exclusive half-day mini-roadshow will bring you to the forefront of current expectations, the likely timetable of changes, how current consultations may influence or impact the proposals, and what will be required to achieve and maintain CE Marking after regulations are passed. We invite you to join our global panel of experts to discuss critical topics and receive valuable insights from the world’s first national standards body.

Please join us in the city nearest you:

Monday, April 28, 2014
Alpharetta, GA Details

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Wednesday, April 30, 2014
Naperville, IL Details

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Friday, May 2, 2014
Austin, TX Details

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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

Dates and Locations

5750 Windward ParkwayAlpharetta, GA 30005

Monday, April 28, 2014

Atlanta Marriott Alpharetta

5750 Windward Parkway
Alpharetta, GA, 30005
United States
770.754.9600
1801 North Naper BoulevardNaperville, IL 60563

Wednesday, April 30, 2014

Chicago Marriott Naperville

1801 North Naper Boulevard
Naperville, IL 60563
United States
630.505.4900
300 E. 4th Street Austin, TX 78701

Friday, May 2, 2014

Courtyard & Residence Inn by Marriott Austin Downtown

300 E. 4th Street
Austin, TX 78701
United States
512.236.8008

Schedule of Events

7:30 am – 8:30 am

Registration Tea/Coffee

8:30 am - 8:40 am

Welcome & Introduction (Paul Brooks)

8:40 am – 9:32 am

Changing & Evolving Requirements for CE marking (Paul Brooks)

9:20 am – 10:00 am

Understanding Clinical Equivalence (Ibim Tariah)

10:00 am – 10:30 am

Top Non Conformities Requiring a Capa Process (Rob Harrison)

10:30 am – 10:45 am

Morning Break

10:45 am – 11:30 am

Risk Management – EN 14971:2012 (Ibim Tariah)

11:30 am – 12:15 pm

Unannounced Audits (Paul Brooks)

12:15 pm – 12:30 pm

Q&A Session

12:30 pm

Meeting Closes

Registration
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