BSI is proud to host our fifth 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 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.
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.
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.
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.
Update on ISO 13485:2016 and possible revision of ISO 14971
Unique Device Identification (UDI)
Clinical Requirements under the MDR
Designing Compliant/Risk Appropriate PMS (and PMCF)
IMDRF Updates – Experience with MDSAP and RPS
IVD Update – Including IVDR Top 10 Interesting Points
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