2017 EU Medical Device Roadshow

Join BSI experts at our full day EU Medical Device 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.

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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 sixth annual EU 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 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

Through the passion and expertise of our people, BSI embeds excellence in organizations across the globe to improve business performance and resilience.

 Our mission is to ensure patient safety while supporting timely access to global medical device technology. We strive to set the global standard in thorough, responsive, predictable conformity assessments, evaluations, and certifications.

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

Erica Conway

Erica Conway

Global Head of the IVD Team

Patricia L. Murphy

Patricia L. Murphy

Global MDSAP Manager

Suzanne Halliday

Suzanne Halliday

Head of BSI Medical Device Notified Body

Gary Slack

Gary Slack

SVP Global Medical Devices

Stefan Burde

Stefan Burde

IVD Product Expert

Bill Enos

Bill Enos

Commercial Director, Medical Devices – Americas

Dr. Ibim Tariah

Ibim Tariah

Technical Director

Ronald Rakos

Ronald Rakos

Operational Effectiveness and Development Lead, Vascular Medical Devices

Paul Sim

Paul Sim

Medical Devices Knowledge Manager

Tony Rizzo

Tony Rizzo

AVP Healthcare Business Development

Vicky Medley

Vicky Medley

Head of QMS - Medical Devices

Topics and Schedule

Detailed listing of our session agenda

8:00am
Breakfast
8:30am
Major Challenges facing Manufacturers under the new MDR and IVDR
  • General overview
  • Legacy Products
  • Transitional Provisions
10:15am
Break
10:30am
Classification Rules and Conformity Assessment
Annex III & PMS Requirements
11:30am
Gap Analysis between the Directive Essential Requirements and the Regulations Safety and Performance Requirements
12:00pm
Lunch
1:00pm
Technology Team examples
1:30pm
Clinical Requirements - MDR
2:15pm
Sterilization and Microbiology – Pitfalls to Avoid 
2:45pm
Break
3:00pm
Labelling
3:30pm
The Last Word on MDSAP
4:00pm
QMS – Aspects of the MDR
4:30pm
Q&A | Close


IVDR Breakout Session

These extra topics are presented as the alternate IVDR Breakout Session.
Please note that the IVDR Breakout sessions are not available at the Newport Beach or Minneapolis locations.

10:30am
Classification rules and conformity assessment
11:15am
Gap analysis between the Essential Requirements and SPRs
1:00pm
Workshop
1:30pm
Clinical Requirements - IVDR

Dates and Locations

Address and contact information for our event venues.


4545 MacArthur Boulevard Newport Beach, CA 92660

Mon, Oct 16, 2017

Carlton Hotel Newport Beach

4545 MacArthur Boulevard
Newport Beach, CA 92660
United States
949.833.0570


2151 Laurelwood Road Santa Clara, CA 95054

Wed, Oct 18, 2017

Biltmore Hotel and Suites

2151 Laurelwood Road
Santa Clara, CA 95054
United States
408.988.8411 


7025 Northland Drive North Brooklyn Park, MN 55428

Fri, Oct 20, 2017

Minneapolis Marriott Northwest

7025 Northland Drive North
Brooklyn Park, MN 55428
United States
763.536.8300


700 Commons Way Bridgewater, NJ 08807

Mon, Oct 23, 2017

Bridgewater Marriott

700 Commons Way
Bridgewater, NJ 08807
United States
908.927.9300


70 3rd Ave. Waltham, MA 02451

Wed, Oct 25, 2017

The Westin Waltham Boston

70 3rd Ave.
Waltham, MA 02451
United States
781.290.5600

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.