2016 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 today!

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 US 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 medical devices 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.

  • "An excellent event! Well organized and the topic on current and upcoming changes were well presented and timely. Thank you!"

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 JPAL, 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://medicaldevices.bsigroup.com

 

Event Speakers and Representatives

John Bis

John Bis

Vice President Healthcare Solutions

Paul Brooks

Paul Brooks

Senior Vice President Healthcare Solutions

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
EU Update - Proposed Regulations, Own Brand Labeling, Unannounced Audits Review
This session will discuss the emerging and changing requirements of the proposed regulations, and how they may impact manufacturers and devices.
9:30-10:15am
Top Ten CE Marking Issues
BSI has helped thousands of companies navigate the regulatory path to achieve CE Marking and entrance into the European Market without costly mistakes, missteps, and myths along the way. This session will discuss the top ten CE Marking issues BSI encounters and how to avoid them.
10:15-10:30am
Break
10:30-11:15am
ISO 13485 Update
The 3rd revision of ISO 13485 is currently under review. This session will discuss the latest updates and timelines around the ISO 13485 revision.
11:15am-12:00pm
Reporting Changes to your Notified Body
When do you report changes to your Notified Body? This session will cover when, what, why, and how to report changes to your Notified Body.
12:00-12:15pm
Closing Remarks

Dates and Location

Address and contact information for our event venue.

475 Technology Parkway Peachtree Corners, GA 30092

Tues, Mar 15, 2016

Atlanta Marriott Peachtree Corners

475 Technology Parkway
Peachtree Corners, GA 30092
United States
770.263.8558


4700 Emperor Boulevard, Durham, NC 27703

Thurs, Mar 17, 2016

Sheraton Imperial Hotel

4700 Emperor Boulevard
Durham, NC 27703
United States
888.627.7057


255 South West Temple, Salt Lake City, UT, 84101

Tues, Apr 5, 2016

Hilton Salt Lake City Center

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


1701 California Street, Denver CO, 80202

Thurs, Apr 7, 2016

Denver Marriott City Center

1701 California St.
Denver, CO 80202
United States
303.297.1300


1801 Naper Blvd Naperville, IL 60563 

Thurs, Apr 21, 2016

Chicago Marriott Naperville

1801 Naper Blvd.
Naperville, IL 60563
United States
630.505.4900


Event Registration

Click to Register for this informative event. You will be taken to a remote site to complete your registration.