The next MedTech Regulatory Special Interest Group (SIG), hosted by regulatory affairs expert Ben Jacoby, from Cambridge RA Ltd, will provide a comprehensive update on the current Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) landscape, plus an overview of the requirements and practical considerations needed within a company to meet regulatory compliance.
The next MedTech Regulatory Special Interest Group (SIG), hosted by regulatory affairs expert Richard Young, from AcclaimBiomedical Consulting Ltd, will provide a comprehensive update on the current Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) landscape, plus an overview of the requirements and practical considerations needed within a company to meet regulatory compliance.
Ben will be joined by Anne Jury, a regulatory affairs consultant with over 18 years experience in the medical and diagnostic healthcare products industries, and Alexander Pearce, Educo Life Sciences, well experienced in helping medical device professionals develop their skills and knowledge through learning and development.
During the presentations, they will cover:
– Introduction to current changes to requirements MDR & IVDR
– ISO13485 minimum Quality Management Systems (QMS) requirements
– Clinical Evidence
– General Safety and Performance Requirements (GSPR)
– Lay Users (individuals who do not have formal education in a relevant field of healthcare or medicine display)
– Roles of the Person Responsible for Regulatory Compliance (PRRC)
– There will be time at the end of the presentations for a Q&A session. Please submit any questions in advance for the panel to discuss during the presentation on the online booking form.
CLICK HERE TO SECURE YOUR PLACE
This free-to-attend event is held as part of the ACTIS programme – a project part-funded by the European Regional Development Fund, click here to be re-directed to further information about the project. This event is classed as State Aid to participating businesses, the value of which is £190, but is delivered completely free of charge to participants.
Please note: whilst this event is held as part of the ACTIS programme, attendance is not restricted to companies in the SEMLEP area and is open to all.
Duration: 1 hour and 30 minutes
Speaker Profiles:
Ben Jacoby, Director, Cambridge RA Ltd
Ben is an experienced regulatory consultant who has worked with clients in the diagnostic, medical device and pharmaceutical industries to help them bring innovative products to market. He provides regulatory and strategic guidance on EU, UK and US issues to clients. Core competencies include technical files, Clinical studies; EU and UK legislation including IVD’s, companion diagnostics and medical devices; EU legislative requirements for instruments; and classification of devices. With more than 25 years of experience in regulatory affairs, he was a European-authorized representative at Ortho-Clinical Diagnostics (a Johnson & Johnson company at the time). He is an effective partner in project management and in achieving goals and deadlines. He is a skilled and persuasive communicator with clients and colleagues at all levels; and flexible and adaptable to changing environments and business needs. Ben has a PhD in Biochemistry from the University of London.
Alexander Pearce, MBA | Director of Educo Life Sciences
Alexander is the Director of Educo Life Sciences, designing learning programmes to meet the needs of life science professionals. He is a specialist in learning product development and was previously Product Manager for a leading Life Science training organisation. He has extensive knowledge of learning pathways, content creation and digital training solutions and was responsible for managing a portfolio of over 300 courses. He was instrumental in designing and delivering online learning solutions.
Alexander is a firm believer that technical training can be delivered in an interactive and impactful way to avoid it being repetitive and boring. He believes training solutions that combine online learning tools and techniques with face-to-face learning delivers greater improved skill retentions and performance.
Alexander has a BSc in Medical Physiology and an MBA from the University of Leicester.
Anne Jury, Director of Anne Jury Associates, Medical Devices Regulatory Affairs Consultancy
Anne Jury is a consultant and trainer in medical devices EU & UK regulatory compliance and quality assurance systems. Starting out as a company microbiologist for Smith & Nephew Textiles Anne went on to work for Notified Bodies, BSI and then TÜV Product Service as a lead auditor and later as UK Regional Manager.
Anne has run her own consultancy business since 2000 providing medical device regulatory support to companies ranging from research institutes and start-up companies to SMEs and multi-national market leaders. Anne was one of the founders and visiting lecturers to the MSc in Medical Technology Regulatory Affairs run by TOPRA and Cranfield University where she was also an external examiner from 2009 to 2012. Anne is also a course leader for Educo Life Sciences, the learning and development specialist, since 2020. Anne is Vice-President of Team-PRRC, a non-profit organization set up in March 2020 to support individuals in the role of PRRC under the EU medical device regulations.
