Medical Device 8th Annual 2019 Roadshow
Join BSI experts at our full-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 the new MDR/IVDR requirements effectively.
Please click above to register for your chosen session location. Hotel information is located below.
Expect the most detailed insights
Hear from the first Notified Body designated to the MDR
BSI hosts our eighth 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 first 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 first notified body designated under the MDR (EU 2017/745). BSI has two European notified body headquarters in the United Kingdom and the Netherlands, both notified bodies are designated for the three Directives (90/385/EEC active implantable medical devices, 93/42/EEC Medical devices and 98/79/EC in vitro diagnostic medical devices directives designations). In addition BSI UK is full scope designated under the MDR.
Topics and Schedule
|8:30 am – 8:50 am||Welcome and Intro|
|8:50 am – 9:50 am
||EU Initial Lessons Learned|
|9:50 am – 10:15 am
||Brexit, Designation, and the EU Landscape|
|10:15 am – 10:30 am
|10:30 am – 11:30 am||Clinical Oversight|
|11:30 am – 12:00 pm||Class IR|
|12:00 pm – 1:00 pm||Lunch|
|1:00 pm-1:30 pm
||Applying for the MDR - New NB Application Process|
|1:30 pm - 2:15 pm
||EU MDR Updates - PSUR, SSCP, Equivalent, Sufficient*|
|2:15 pm – 2:45 pm||Key Standards Updates|
|2:45 pm - 3:00 pm||Coffee Break|
|3:00 pm – 3:45 pm||QMS Aspects of MDR|
|3:45 pm – 4:15 pm
||EU MDR Updates - EUDAMED, Implant Card*|
|*Periodic Safety Update Report (PSUR), Summary of Safety & Clinical Performance (SSCP), user information for implantable devices (such as Implant Cards), European Database on Medical Devices (EUDAMED)|
The advantage of an industry-leading Medical Device team
Our Global Medical Device team is composed of more than 600 experts in medical technology with extensive experience in regulatory, industry and academic areas. Your presenters for this conference include:
John has over 25 years of experience in the Healthcare industry. John works with professionals and organizations who serve the medical industry world-wide. John is driven to ensure BSI clients are provided quality services that include but not limited to; Assessments, CE Marking, Business Management Software Tools, Training, Resource Tools and Technical Expertise that ensure that our clients succeed in regard to bringing quality products to the healthcare market. John leads a highly talented team of account managers who support our clients.
Suzie is Head of BSI Medical Device Notified Body, she has fifteen years of experience within the Notified Body. For eight years Suzie lead the Orthopedic and Dental team, with responsibilities for aspects of EN ISO 13485 and CE Marking for all global clients. The team was also responsible under numerous Mutual Recognition Agreements for aspects of compliance in Canada, USA, Japan, Taiwan and Australia. In her current role, she develops processes for the Medical Devices team to ensure compliance with global regulatory requirements. Prior to Suzie’s work at BSI she completed a Bachelor Degree and Masters in Science (University of Waterloo) and a Doctorate in Engineering (University of Oxford). Suzie has worked in orthopedic hospitals in Australia, Canada, Japan, UK and the USA, testing joint replacement implants, spinal and fracture fixation systems. She has also lead clinical investigations on orthopedic implants.
Paul Mayon is experienced, self-motivated and ethical professional committed to high standards, he has a proven track record of delivery that shows in-depth knowledge of safe and effective development of medical devices and the regulatory processes that support them. Paul is a biomechanical engineer who has 22 years’ experience working in large multi-region medical device companies. Paul’s aim is to continue to offer BSI and its clients immediate and strategic value that focuses on excellence
Bill Enos is the Senior Commercial Director, Medical Devices – Americas and has been with BSI for more than 15 years. Bill is now responsible for leading BSI activities in the medical devices regulatory sector for the Americas region including EU Notified Body, ISO 13485 Certification, Health Canada / SCC CMDCAS accreditation and MDSAP Auditing Organization recognition. Previously Bill was the Global Head of Microbiology at BSI. His responsibilities include auditing quality systems and review of technical files and other certification activities related to sterile medical devices. Before joining BSI, Bill was vice president for technical sales and business development at Microtest Laboratories, where he was involved with all aspects of medical device, pharmaceutical testing and manufacturing. Bill was with Microtest for eleven years and held several positions, including laboratory technician, laboratory manager, and director of quality systems, ultimately leaving after the vice president position. Bill is a published author, BSI tutor and trainer, auditor, and technical specialist. Bill received his Bachelor of Science degree in microbiology in 1993 from Western New England University.