2018 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 changes to the European Regulatory and Compliance Expectations for CE marking. Enabling you to prepare for future requirements effectively.


Are you prepared for the significant changes to European regulations in order to maintain your CE marking?

BSI is proud to host our seventh 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 event exclusively focused on addressing European medical device regulatory and quality assurance requirements. BSI will be sharing our current experiences, best practice and expectations from the perspective of the leading global medical device Notified Body, ISO 13485 registrar, MDSAP Auditing Organization and world’s first national standards body.

We invite you to join our international panel of experts to discuss critical topics and receive valuable insights around the significant changes we are all facing in 2018 and beyond.

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

The BSI Medical Device 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.

BSI Group equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. From assessment, certification and training to software solutions, advisory services and supply chain intelligence*, BSI provides the full solution to facilitate business improvement and helps clients drive performance, manage risk and grow sustainably. For organizations large and small, BSI enables resilience by embedding excellence to create relevant, safer and more secure products/services leveraging the passion and expertise of our people. Renowned for its marks of excellence, BSI’s influence spans across multiple sectors with a particular focus on Aerospace, Automotive, Built Environment, Food, Retail, Healthcare and IT.

The Advantage 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, a fully recognized Auditing Organization (AO) under the Medical Device Single Audit Program and recognized by 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 global Medical Device team is composed of more than 140 technical experts and over 200 Auditors in medical technology with a combined 3,000 years of regulatory, industry and academic experience. With experience in all risk-class device profiles, including established and novel technologies, our team can offer your organization, from new venture to complex multi-national, the total solution to navigate the regulatory pathways and demonstrate robust compliance.

* If an organization is certified with BSI to a management system, please note that BSI will not provide consulting services for that particular management system due to impartiality requirements.

Supporting your medical device business

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 knowledgeable resources. By choosing BSI, our customers can depend on more than just technical competence; we continually build long-term working relationships to allow robust reviews, deliver predictability and confidence that meet each customer’s unique needs.



Event Speakers and Representatives

Complete list of event speakers is not yet finalized. Please check back later for more information.

Topics and Schedule

Detailed listing of our session agenda

8:30am - 9:00am
Welcome and Intro
9:00am - 10:00am
Highlights of the MDR
10:00am - 10:15am
Coffee Break
10:15am - 11:30am
A Holistic Approach to Clinical Requirements
11:30am - 12:00pm
Labelling and UDI
12:00pm - 1:00pm
1:00pm - 1:45pm
1:45pm - 2:15pm
Requirements & considerations for Technical Documentation under the MDR
2:15pm - 2:45pm
2:45pm - 3:00pm
Coffee break
3:00pm - 3:30pm
Key Standards Update
3:30pm - 4:00pm
QMS Implications of the MDR

Dates and Locations

Address and contact information for our event venues.

One Burlington Mall Road, Burlington, MA 01803

Wed, Sep 5, 2018

Boston Marriot Burlington

One Burlington Mall Road,
Burlington, MA 01803
United States

700 Commons Way Bridgewater, NJ 08807

Fri, Sep 7, 2018

Bridgewater Marriott

700 Commons Way
Bridgewater, NJ 08807
United States

2151 Laurelwood Road Santa Clara, CA 95054

Mon, Sep 10, 2018

Biltmore Hotel and Suites

2151 Laurelwood Road
Santa Clara, CA 95054
United States

4545 MacArthur Boulevard Newport Beach, CA 92660

Wed, Sep 12, 2018

Hyatt Regency John Wayne Airport, Newport Beach

4545 MacArthur Boulevard
Newport Beach, CA 92660
United States

7025 Northland Drive North Brooklyn Park, MN 55428

Fri, Sep 14, 2018

Minneapolis Marriott Northwest

7025 Northland Drive North
Brooklyn Park, MN 55428
United States

Event Registration

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

Registration for this Roadshow is now closed.