2015 EU Medical Device 4th 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 fourth 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 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.

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://medicaldevices.bsigroup.com

 

Event Speakers and Representatives

Neil Adams

Neil Adams

Director, Operations and Delivery, BSI

John Bis

John Bis

Vice President Healthcare Solutions

Paul Brooks

Paul Brooks

Senior Vice President Healthcare Solutions

Stefan Burde

Stefan Burde

IVD Product Expert

Bill Enos

Bill Enos

Global Head of Microbiology

Suzanne Halliday

Suzanne Halliday

Head of Medical Devices - Notified Body 0086

Vicky Medley

Vicky Medley

Head of QMS - Medical Devices, BSI,  

Tony Rizzo

Tony Rizzo

AVP Healthcare Business Development, BSI

Gary Slack

Gary Slack

Senior Vice President of Global Healthcare Solutions

Sue Spencer

Sue Spencer

Head of IVD

Richard Stein

Richard Stein

Product Expert Active Implantable Medical Devices, BSI

Dr. Ibim Tariah

Dr. Ibim Tariah

Technical Director

Topics and Schedule

Detailed listing of our session agenda

8:00-8:30am
Registration & Breakfast
8:30-8:45am
Welcome & Introduction
8:45-9:30am
EU Update - Proposed Regulations, Own Brand Labeling, Unannounced Audits
Review proposed regulations, own brand labeling, and unannounced audits. 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
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.
10:15-10:30am
Break
10:30-11:15am
Clinical Evaluation - Med Dev 2.7.1
Understanding and demonstrating clinical equivalence is critical within the context of conducting clinical evaluations and determining whether new investigations are required. This session will review the proposed requirements.
11:15am-12:00pm
Vigilance Reporting
Proactive and reactive sources of information are a regulatory requirement to be incorporated in your post-market surveillance procedures and are applicable to all products. This session will offer guidance on what needs to be reported.
12:00-1:00pm
Network Lunch
1:00-1:45pm
Medical Device Single Audit Program and J-PAL
The distribution of medical devices in Japan is regulated in accordance with the Pharmaceutical and Medical Device Act (PMD Act) regulation by the Ministry of Health, Labour and Welfare (MHLW). The Medical Device Single Audit Program (MDSAP) is an international initiative led by Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements. This session will provide an update on both the PMD Act and current status/findings of MDSAP. 
1:45-2:30pm
Usability & Human Factors
Human factors and usability engineering focuses on the synergy of human operators, or users with systems, and their UIs by applying knowledge of human capabilities and limitations and performing tests and evaluations of user/system performance. This session focuses on the growing importance of usability and human factors during product development.
2:30-2:45pm
Break
2:45-3:30pm
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.
3:30-4:15pm
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.
4:15-4:30pm
Closing Remarks


IVD Breakout Session

These extra topics are presented as the additional IVD Breakout Session.
Please note that the IVD Breakout Sessions is only available in Santa Clara, Irvine, and Waltham.

10:30am-12:00pm
Changes to the IVDR including the substantial changes described in the June 2015 draft
What are the changes including the latest amendments. This session will provide a holistic overview on the fundaments of the IVDR.
1:00-2:00pm
IVDR Implementation Workshop
Using examples in a workshop investigate how to implement the IVDR from classify the device to using existing data for established products. This session is an interactive workshop where attendees will collaborate with their peers.
2:00-2:30pm
IVD Market Needs
What are IVD manufacturers looking for?  Will they want gap analysis?  When will they start implementation? What are their key concerns? This session will address the market needs and how to avoid being left behind.

Dates and Locations

Address and contact information for our event venues.

2151 Laurelwood Road, Santa Clara, CA 95054

Mon, Sept 14, 2015

Biltmore Hotel and Suites

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


4545 MacArthur Boulevard, Newport Beach, California 92660

Wed, Sept 16, 2015

Radisson Hotel Newport Beach

4545 MacArthur Boulevard,
Newport Beach, California 92660
United States
800.333.3333


550 Winter Street, Waltham, Massachusetts 02451

Fri, Sept 18, 2015

Embassy Suites Boston/Waltham

550 Winter Street,
Waltham, Massachusetts 02451
United States
781.890.6767


9960 Wayzata Boulevard, Minneapolis, Minnesota 55426

Mon, Sept 21, 2015

Minneapolis Marriott West

9960 Wayzata Boulevard,
Minneapolis, Minnesota 55426
United States
952.544.4400

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.