BSI Consultant Day am 12. Oktober in Frankfurt am Main

Jay is a Regulatory Director within BSI and the Head of the Notified Body for Medical Devices. He is responsible for the regulatory oversight of Notified Body activities for medical devices and wider BSI strategy, policies, procedures, and documentation to meet the various legislative and designation requirements. He has held other BSI roles such as Head of UK Approved Body, Head of Training, Technical Team Manager, Technical Specialist & Scheme Manager prior to the current position.

Prior to joining BSI, Jay was the Chief Scientist at a start-up medical device company developing innovative soft tissue repair and replacement therapies. He holds a PhD in Biomedical Engineering from the University of Leeds.

Vishal joined BSI over 6 years ago and is currently the Head of the UK Approved Body and a Senior Regulatory Lead for Medical Devices. He is responsible for the regulatory oversight of the Medical Devices Approved Body and wider BSI strategy, policies, procedures, and documentation to meet the various legislative and designation requirements. Prior to his current role, he has been a Regulatory Lead, Technical Team Manager, Technical Specialist & Scheme Manager with expertise in Active Devices.

Vishal holds a Masters in Medical Engineering from Queen Mary University of London and has over 10 years’ experience with medical devices working within industry, third party testing and Notified/Approved Body.

Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specializing in implantable cardiac devices and electro physiology.

Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organization. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.

Daniela joined BSI in 2017 as Technical Specialist, Scheme Manager and Clinical Team Lead in the Active Medical Devices Team and is currently Regulatory Lead Artificial Intelligence (AI), responsible for AI regulatory strategy, policies, procedures and accreditation/designation as a Conformity Assessment Body and Notified Body. Her main role is to establish and maintain compliance to regulatory requirements in terms of organizational, quality management processes and resources, supporting Operations in the certification activities and training program.

Daniela holds Bachelors and Masters in Biomedical Engineering, a Masters in Health Technology Assessment and has over 17 years’ experience in medical devices, including AI software, having worked in technology development, technology transfer, patents, testing, clinical studies and as medical device lead auditor/national expert for the Italian Ministry of Health in the European Commission working groups and Joint Assessments. She is a former IEEE member actively participating to the CEN-CENELEC Joint Technical Committee 21 on Artificial Intelligence.

Dominik Liebetrau works as Technical Sales Manager at BSI Group Deutschland GmbH and has more than 10 years of experience in the DACH region. Specialising in system certification, Dominik combines his experience with BSI's best practices to help organisations find the right path for their certification structure, increasing the value of their certifications and the confidence of their customers.