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2015
Mini-Roadshow

The 2015 Medical Device Mini-Roadshow

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

Update on EU Regulatory Requirements for Medical Devices and Understanding CE Marking Technical Documentation/Clinical Evaluation Expectations

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:

Tues, Mar 10, 2015
Saint Petersburg, FL Details

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Thurs, Mar 12, 2015
Memphis, TN Details

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Tues, Apr 14, 2015
Broomfield, CO Details

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Thurs, Apr 16, 2015
Naperville, IL 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

950 Lake Carillon Drive, Saint Petersburg, FL 33716

Tues, Mar 10, 2015

Hilton St. Petersburg Carillon Park

950 Lake Carillon Drive,
Saint Petersburg, FL 33716
United States
727.540.0050
5795 Poplar Avenue, Memphis, TN 38119

Thurs, Mar 12, 2015

Marriott Memphis East

5795 Poplar Avenue,
Memphis, TN 38119
United States
901.682.0080
13351 W. Midway Blvd. Broomfield, CO 80020

Tues, Apr 14, 2015

Hyatt House Boulder/Broomfield

13351 W. Midway Blvd.
Broomfield, CO 80020
United States
720.890.4811
1801 N. Naper Blvd. Naperville, IL 60563

Thurs, Apr 16, 2015

Chicago Marriott Naperville

1801 N. Naper Blvd.
Naperville, IL 60563
United States
630.505.4900

Topics

8:00 am – 8:30 am

Registration and Breakfast

8:30 am - 12:30 pm

Meeting

Event Topics

  • European Regulatory Update - CE, 13485, OBL
  • Clinical Data Evaluation - Lesson's Learned
  • Compliance Navigator & Action Manager
  • Technical Files - Key Pitfalls
  • Unannounced Audits & MDSAP Update
Registration
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