2018 EU Medical Device Spring-Roadshow

Join BSI experts at our half-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.

Register

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

BSI is proud to host our fourth annual EU Medical Device Spring 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 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 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 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 new venture to complex multi-national, the total solution to navigate the regulatory pathways and demonstrate robust compliance.

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.

http://www.bsigroup.com/en-US/medical-devices/

ROBUST

Event Speakers and Representatives

Bill Enos

Bill Enos

Commercial Director, Medical Devices – Americas

Dr. Ibim Tariah

Ibim Tariah

Technical Director

John Bis

John Bis

VP Medical Devices Solutions Sales

Topics and Schedule

Detailed listing of our session agenda

8:30am - 9:00am
EU Regulations – What’s changing and why?
9:00am - 10:15am
MDR – Classification, Conformity Assessment, GSPRs, Technical Documentation/PMS
10:15am - 10:30am
Coffee Break
10:30am - 11:00am
ISO 13485:2016 and MDSAP updates
11:00am - 12:00pm
MDR – Risk and Clinical Requirements

Dates and Locations

Address and contact information for our event venues.


7401 164th Avenue NE, Redmond, Washington 98052

Tues, Mar 6, 2018

Marriott Seattle Redmond

7401 164th Avenue NE
Redmond, Washington 98052
United States
425.498.4000


7000 Church Ranch Blvd, Westminster, CO 80021

Thurs, Mar 8, 2018

Denver Marriott Westminster

7000 Church Ranch Blvd
Westminster, CO 80021
United States
720.887.1177 


1801 N Naper Blvd, Naperville, IL 60563

Tues, Apr 17, 2018

Chicago Marriott Naperville

1801 N Naper Blvd
Naperville, IL 60563
United States
630.505.4900


6080 Viscount Road Mississauga, ON L4V 0A1 Canada

Thurs, Apr 19, 2018

ALT Hotel Toronto Airport

6080 Viscount Road
Mississauga, ON L4V 0A1
Canada
855 855-6080


5993 Peachtree Industrial Blvd., Peachtree Corners, GA 30092

Thurs, May 10, 2018

Hilton Atlanta Northeast

5993 Peachtree Industrial Blvd.
Peachtree Corners, GA 30092
United States
770-447-4747

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.