Presented by
Management Forum
This webinar has been designed to help you understand the ‘big picture’ of competence management, from selection of the right competencies for success to the maintenance of collective organisational knowledge.
Many medical device developers and manufacturers rely heavily on the competence of their staff to achieve their business goals. Like many companies, particularly in the start-up phase, it can be a daunting task to know where to start with documenting the necessary evidence to demonstrate that competence to third parties such as investors and notified or approved bodies.
Under the MDR / IVDR, the requirement to have a Person Responsible for Regulatory Compliance brings the need to demonstrate competence into even sharper focus.
This webinar has been developed to help you understand the ‘big picture’ of competence management from selection of the right competencies for success to maintenance of collective organisational knowledge.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Anne Jury is a regulatory affairs consultant with over 25 years experience in the medical and diagnostic healthcare products industries. With a degree in Microbiology, she went to work as company microbiologist for Smith & Nephew Textiles on sterile wound dressing products. Later she went on to work for Notified Bodies, BSI and then TÜV Product Service as a lead auditor covering over 200 medical companies in Europe and USA.
Anne is a member of TOPRA, (The Organisation for Professionals in Regulatory Affairs) and RAPS, (Regulatory Affairs Professionals Society) and a regular speaker at conferences world-wide. Through close association with like minded organizations such as Medilinks, the DTI and NHS Innovations Hubs as well as biotechnology incubators around the UK, she is active in the promotion of integrated management and regulatory systems to assist the successful introduction of new products to market.
Since March 2020, she is also Vice President of Team-PRRC.
Specialties: Technical guidance on regulatory strategies and quality management systems for new medical device product commercialization, including CE marking requirements, implementation of management systems to ISO 13485:2016 and training / coaching in these areas.
Gap analysis compliance audits for manufacturers and subcontract third party auditor for Notified Bodies.
Past visiting lecturer at Cranfield University (through TOPRA) on MScs in Medical Technology Regulatory Affairs.
Vice-President of Team-PRRC, a non-profit association in EU to support those taking on the PRRC role under MDR and IVDR.
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26 March 2025
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14:00-15:30 UK (London) (UTC+00)
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Course code 14661
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11 July 2025
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Course code 15244
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11 November 2025
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Course code 15039
Until 07 Oct
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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
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