Access to the UK Market for Dental Devices

Webinar

Access to the UK Market

for Dental Devices 

Guest speakers from BSI 

Tuesday, March 28^th, 2023   |    14:00 – 15:30 (IL) 

Agenda: 

14:00 – 14:05     Opening remarks

Ron Pando, Head of Biotech and Dental Sectors, Israel Export Institute 

14:05 – 15:00     Access to the UK Market for Dental Devices 

Vishal Thakker, Head of UK Approved Body & Senior Regulatory Lead, BSI

Purvi Pat, Regulatory Lead • Regulatory Services - Notified Body, BSI 

15:00 - 15:30      Access to the EU Market for Dental Devices

Dr. Tamar Katzav, VP Project Management, Physio-Logic    

Moderator:  Dr. Tamar Katzav, VP Project Management, Physio-Logic   

About the speakers:     

Vishal Thakker - Head of UK Approved Body & Senior Regulatory Lead, BSI

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.      

Purvi Patel  - Regulatory Lead • Regulatory Services - Notified Body, BSI

Purvi is a Regulatory Lead at BSI who speaks in Europe about how the MDR and UKCA is changing the regulatory landscape for medical devices.  Currently, she is working on CE schemes and also the implementation of UKCA legislation at BSI.  Purvi has an extensive background in conducting technical reviews under the MDR/MDD for orthopaedic and dental devices.  Prior to joining BSI over 5 years ago, Purvi has held various positions in the medical devices industry working at Zimmer Biomet, Renishaw plc, Surgicraft Ltd. and Finsbury Orthopaedics Ltd.  Purvi holds a Master's degree (Biomedical Engineering) and PhD (Screw Fixation of Implants to the Spine) from the University of Birmingham (UK) and has over 15 years of experience working with medical devices in academia, industry and the Notified/Approved Body.  

Dr. Tamar Katzav  - VP Project Management, Physio-Logic

Tamar brings forward over 15 years of experience in leading quality assurance, compliance and regulation of medical devices, active substances, and drugs. Tamar managed medical device regulatory teams in global companies including submissions and maintenance of registration in different territories including 510(k), CE Marking and AMAR submissions. Tamar manages the area of In-Vitro -Diagnostics (IVD) regulation in the company and has extensive experience in this field. Tamar is a certified Internal Auditor according to ISO 13485: 2016 and 21 CFR 820.