2017 EU Medical Device Mini-Roadshow

Join BSI experts at our half day Mini-Roadshow where you can learn about some of the most significant evolving European Regulatory and Compliance Expectations for CE Marking to help prepare for future requirements.

Register

Evolving European Medical Device Regulatory Requirements and the Impact on Achieving and Maintaining CE Marking

BSI is proud to host our Medical Device Mini-Roadshow for the medical device manufacturer regulatory affairs, quality assurance and related consulting community. Our unique half-day Medical Device Roadshow event is the only annual North American located event exclusively focused on addressing European medical device regulatory and quality assurance requirements and sharing current experience, best practice and expectations from the perspective of the leading reviewer of CE Marking, ISO 13485 and MDSAP certification relating to medical devices manufacturers in North America.
We invite you to join our global panel of experts to discuss critical topics and receive valuable insights from the leading medical device Notified Body, ISO 13485 registrar and worlds first national standards body.

Please join us in the city nearest you.

  • "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."

BSI Medical Roadshow 2015

About BSI

BSI is the sector leading standards authority, training organization, third-party certification body, ISO registrar and information solutions provider. Backed by 90,000 client locations in over 150 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 directives relevant to medical device manufacturers and recognized by FDA, Health Canada CMDCAS, Japan MHLW PMD Act, Australian TGA and many other regulatory authorities. 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— true experts in device technology and manufacturing processes many of them holding patents in their respective fields. With experience in all risk-class device profiles, including established and novel technologies, our team can offer your organization, from small new venture to complex multi-national, the 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 and quality issues with the efficiency, certainty and cost-effectiveness of a global network of expert resources. By partnering with BSI, our customers can depend on more than just technical competence; we continually build long-term working relationships to overcome challenges, deliver predictability and confidence that meet each customer’s unique needs.

http://www.bsigroup.com/en-US/medical-devices/

 

Event Speakers and Representatives

Ronald Rakos

Ronald Rakos, Ph.D., MBA, RAC

Global Head, Vascular Medical Devices

Tony Rizzo

Tony Rizzo

AVP Healthcare Business Development

John Bis

John Bis

VP Medical Devices Solutions Sales

Dr. Ibim Tariah

Dr. Ibim Tariah

Technical Director

Topics and Schedule

Detailed listing of our session agenda

8:00-8:30am
Registration & Breakfast
8:30-8:35am
Welcome & Introduction
8:35-9:30am
Med Dev Reg Update
9:30-10:15am
Medical Device Single Audit Program (MDSAP)
10:15-10:30am
Break
10:30-10:45am
ISO 13485 Update
10:45-11:45am
Med Dev 2.7.1 Rev 4
11:45am-12:00pm
Closing Remarks

Dates and Locations

Address and contact information for our event venues.


2519 East Center Street, Warsaw, IN 46580

Tues, Mar 21, 2017

Wyndham Garden Warsaw

2519 East Center Street
Warsaw, IN 46580
United States
574.269.2323


6257 Airport Road, Mississauga, Ontario L4V 1E4

Thurs, Mar 23, 2017

Four Points by Sheraton Toronto Airport

6257 Airport Road
Mississauga, Ontario L4V 1E4
Canada
905.678.1400 


10600 Westminster Blvd, Westminster, CO 80020

Tues, April 11, 2017

The Westin Westminster

10600 Westminster Blvd
Westminster, CO 80020
United States
303.410.5000


255 South West Temple Salt Lake City, UT 84101

Thurs, April 13, 2017

Hilton Salt Lake City Center

255 South West Temple
Salt Lake City, UT 84101
United States
801.328.2000


300 E. 4th Street, Austin, TX 78701

Tues, May 2, 2017

Courtyard Austin Downtown/Convention Center

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

Event Registration

Please select a location and the session options that you would like to attend and click to Register. You will be taken to a remote site to complete your registration.