Hear from a world-class Notified Body
BSI hosts our ninth annual EU Medical Device Roadshow for the medical device manufacturer regulatory affairs, quality assurance and related consulting community.
Join us for the first ever virtual version of our Medical Device Roadshow 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 is a trusted, world-class Notified Body and Conformity Assessment Body dedicated to providing rigorous regulatory and quality management reviews and product certifications for medical device manufacturers around the world.
BSI Medical Devices has a team of over 700. Within that team are our technical experts with experience encompassing the full range of medical devices and management system standards. Our services include system certification to ISO 13485, CE marking, product testing, and standardization to support your global market access goals.
BSI has two Notified Bodies, one in the UK (0086) and one in the Netherlands (2797), both of which have full scope designations to the IVDR and MDR.
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, robust conformity assessments, evaluations and certifications.
Topics and Schedule (All Times are EST)
| Tuesday October 13, 2020 | |
| 12:00 – 12:30 pm | MDR application process |
| 12:30 – 1:00 pm | Top 10 gaps in initial MDR assessments |
| 1:00 – 1:30 pm | Standards update |
| 1:30 – 1:40 pm | Break |
| 1:40 – 2:40 pm | MDR technical documentation – lessons learned |
| 2:40 – 3:00 pm | Codes and sampling |
| Wednesday October 14, 2020 | |
| 12:00 – 1:00 pm | Clinical evaluation and relevant MDCG guidance |
| 1:00 – 1:30 pm |
Commission - Status on Expert Panels |
| 1:30 – 1:40 pm | Break |
| 1:40 – 2:40 pm | MDR post-market surveillance |
| 2:40 – 3:00 pm | Reporting changes |
| Thursday October 15, 2020 | |
| 12:00 – 12:30 pm | EU – new MDCG guidance and regulatory updates |
| 12:30 – 1:00 pm |
Unique Device Identification |
| 1:00 – 1:30 pm | MHRA’s forward looking stance on Post-Brexit |
| 1:30 – 1:40 pm | Break |
| 1:40 – 2:10 pm | ISO 14971 |
| 2:10 – 2:40 pm | Notified Body’s take account of MDSAP Reports |
| 2:40 – 3:00 pm | Closing remarks |
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 Orthopaedic and Dental team, with responsibilities for aspects of EN ISO 13485 and CE Marking for all global clients. 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).In her current role, she develops processes for the Medical Devices team to ensure compliance with global regulatory requirements.
Elizabeth Champagne is a technical specialist and scheme manager with BSI for 2.5 years. She specializes in delivery of conformity assessments for vascular devices as well as training in regulatory areas of subject matter expertise. Prior to her work with BSI, she has over 10 years of experience in the medical device industry in various product development engineering and product management roles. She holds a Bachelor's degree in Biomedical Engineering from the University of Iowa and a MBA from Indiana University.
Maddalena holds a Master Degree in Medical Biotechnology and has more than 10 years’ experience in regulatory affairs within the medical device industry. During her industry career, she developed and executed global regulatory strategies to secure regulatory approvals on a global scale, translating regulatory requirements into project/product requirements. In her current role in BSI, she develops policies and processes for the Medical Devices team to ensure compliance with EU regulatory requirements.
Jayanth is the Senior Regulatory Lead for the BSI UK Notified Body and working along with the Head of the Notified Body is responsible for the regulatory oversight of Medical Devices Notified Body strategy, policies, procedures and documentation to meet the various legislative and designation requirements. He has held other roles such as Head of Training, Technical Team Manager, Technical Specialist & Scheme Manager before taking up the current position of Senior Regulatory Lead.
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
As a technical team manager and technical specialist for BSI, Alexandra manages CE Marking certification schemes and is a technical reviewer for vascular devices including stents and other catheter-based devices. She is a co-author of a whitepaper on the MDR Annex I Safety & Performance Requirements. Alexandra has been with BSI since 2014. Prior to BSI, Alexandra worked for several years in Product Development for vascular stents at Cook Medical. Alexandra holds several US patents for medical devices and is a contributing author in 10 peer-reviewed research publications in the area of vascular devices and vascular biology.
Jaishankar Kutty, Ph.D., Technical Team manager, Vascular team, has served in various capacities ranging from technical reviewer/scheme manager to clinical team leader along with sharing technical team leadership responsibilities at BSI, for more than 6 years. Previously, he has been involved in the design, development and clinical trials of significant structural heart devices, vascular closure, renal denervation, and research focused on tissue engineering approaches towards wound healing.
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.
BSI is the business improvement company that enables organizations to turn standards of best practice into habits of excellence. For over a century BSI has championed what good looks like and driven best practice in organizations around the world. Working with 84,000 clients across 193 countries, it is a truly international business with skills and experience across a number of sectors including aerospace, automotive, built environment, food, and healthcare. Through its expertise in Standards Development and Knowledge Solutions, Assurance Services, Regulatory Services and Consulting Services*, BSI improves business performance to help clients grow sustainably, manage risk and ultimately be more resilient and trusted. To learn more, please visit: www.bsigroup.com
* Due to BSI’s role as a designated EU Notified Body, no BSI group company may provide any form of consultancy that could be in breach of the Medical Devices Regulation. No BSI group company may provide consultancy services to medical device manufacturers, commercial competitors or suppliers to the manufacturers. Consultancy clients are unable to take certification services from BSI within three years of the completion of the consultancy.
