Learning Marketplace

2018 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.

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.

Topics and Schedule

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

About BSI

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.