2016 EU Medical Device 5th Annual Roadshow

Join BSI Experts at the Premier US Annual Conference Focused on Evolving European Regulatory and Compliance Expectations for CE Marking Today and Prepared for Future Requirements.

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

BSI is proud to host our fifth annual Medical Device Roadshow for the medical device manufacturer regulatory affairs, quality assurance and related consulting community. Our unique full-day Medical Device Roadshow event is the only annual education event exclusively focused on addressing European medical device regulatory and quality assurance landscape, and sharing current experience, best practice and latest expectations from the perspective of the leading provider of CE Marking, ISO 13485 and MDSAP certification relating to medical devices manufacturers in North America.

BSI will review the EU regulations and provide expert practical implementation information at the Roadshows.

We invite you to join our panel of experts and networking with colleagues from the medical device RA/QA community to discuss critical updates 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 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://www.bsigroup.com/en-US/medical-devices/

 

Event Speakers and Representatives

Stefan Burde

Stefan Burde

IVD Product Expert

Erica Conway

Erica Conway

Global Head of the IVD Team

Bill Enos

Bill Enos

Global Head of Microbiology

Suzanne Halliday

Suzanne Halliday

Head of Medical Devices - Notified Body 0086

Patricia Murphy

Patricia Murphy

Global MDSAP Manager

Debbie Petit

Debbie Petit

Client Manager

Ronald Rakos

Ronald Rakos, Ph.D., MBA, RAC

Global Head, Vascular Medical Devices

Paul Sim

Paul Sim

Medical Devices Knowledge Manager

Gary Slack

Gary Slack

Senior Vice President of Global Healthcare Solutions

Dr. Ibim Tariah

Dr. Ibim Tariah

Technical Director

Topics and Schedule

Detailed listing of our session agenda

8:30-8:45am
Welcome & Introduction
8:45-9:45am
Update on ISO 13485:2016 and possible revision of ISO 14971
9:45-10:15am
Reprocessing/Remanufacturing
10:15-10:30am
Coffee Break
10:30am-12:00pm
Medical Device Regulations Update – Top 10 Issues
12:00-1:00pm
Networking Lunch
1:00-2:00pm
MEDDEV 2.7.1 Rev 4 Clinical Requirements
2:00-2:15pm
Virtual Manufacturers and Own Brand Labeling Update
2:15-2:30pm
Coffee Break
2:30-3:15pm
Designing Compliant/Risk Appropriate Post Market Surveillance (and PMCF)
3:15-4:00pm
MDSAP Update


IVD Breakout Session

These extra topics are presented as the additional IVD Breakout Session.
Please note that the IVD Breakout sessions are not available at the Minneapolis location.

10:30am-12:00pm
In Vitro Diagnostics Regulations Update - Top 10 Issues
1:00-2:00pm
IVDR Transition Planning

Dates and Locations

Address and contact information for our event venues.


One Burlington Mall Road, Burlington, MA 01803

Mon, Oct 3, 2016

Boston Marriott Burlington

One Burlington Mall Road,
Burlington, MA 01803
United States
781.229.6565


1251 US-202 Bridgewater, NJ 08807

Wed, Oct 5, 2016

Bridgewater Manor

1251 US-202,
Bridgewater, NJ 08807
United States
908.658.3000


1500 Park Place Blvd., Minneapolis, Minnesota, 55416

Fri, Oct 7, 2016

DoubleTree Minneapolis – Park Place

1500 Park Place Blvd.,
Minneapolis, MN, 55416
United States
952.542.8600


2151 Laurelwood Road, Santa Clara, CA 95054

Mon, Oct 10, 2016

Biltmore Hotel and Suites

2151 Laurelwood Road,
Santa Clara, CA 95054
United States
800.255.9925


4545 MacArthur Boulevard Newport Beach California 92660

Tues, Oct 11, 2016

Radisson Hotel Newport Beach

4545 MacArthur Boulevard,
Newport Beach CA 92660
United States
949.833.0570

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.