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.
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.
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.
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.
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