2017 EU Medical Device 6th Annual Roadshow
Join BSI experts at our full day EU Medical Device Roadshow where you can learn about some of the most significant evolving European Regulatory and Compliance Expectations for CE marking to help prepare for future requirements.
Early Bird registration price of $125 until September 16. Register today!
Evolving European Medical Device Regulatory Requirements and the Impact on Achieving and Maintaining CE Marking
BSI is proud to host our sixth 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 located 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, ISO 13485 and MDSAP certification relating to medical devices manufacturers 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.
| 8:00am|| Breakfast
|8:30am|| Major Challenges facing Manufactures under the new MDR and IVDR
- General Overview
- Legacy Products
- Transitional Provisions
|10:30am|| MDR Breakout|
- Classification Rules and Conformity and Assessment
- Annex III & PMS Requirements
|11:30am|| Gap Analysis between the Directive Essential Requirements and |
the Regulations Safety and Performance Requirements'
|1:00pm||Technology Team examples|
|1:30pm||Clinical Requirements - MDR |
|2:15pm||Sterilization and Microbiology - Pitfalls to Avoid |
|3:00pm||Labeling (MDR Requirements & Progress on Standards |
|3:30pm||The Last Word on MDSAP|
|4:00pm||QMS - Aspects of the MDR |
|4:30pm||Q&A | Close |
Through the passion and expertise of our people, BSI embeds excellence in organizations across the globe to improve business performance and resilience.
Our 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.
The Support 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 and recognized by FDA, Health Canada CMDCAS, Japan MHLW PMD Act, 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.
Expertly Driven Partnerships
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.