RAPS UK LNG: Status of post-Brexit UK MDR and Harmonized Standards

When:  Sep 21, 2021 from 17:00 to 18:30 (ET)

The RAPS UK Local Networking Group (UK LNG) is offering a series of complimentary webinars as part of its 2021 post-COVID Relaunch. You are invited to the second of three virtual events on the "Status of post-Brexit UK MDR and Harmonized Standards".

Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Learning Objective

Status of post-Brexit UK MDR and Harmonized Standards

Who Should Attend?

UK LNG members but also non members


Robert Turpin, Head of Sector (Healthcare), BSI Group

Nele Zgavc, Lead Standards Development Manager, BSI Group

Richard Bancroft, Science and Technical Director, STERIS

Lena Cordie-Bancroft, President/Principal Consultant, Qualitas Professional Services, LLC

Lena Cordie has over 20 years of quality and project management experience including: • 10 years in project management at Target Financial Services; • 11 years as Direct of Operations at Key Surgical; • 4+ years as President, Consultant at Qualitas Professional Services. As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on training and helping companies implement quality management systems, UDI solutions for labelling and GUDID submissions, and providing internal audit, validation, documentation and project management resources to medical device companies. She is an active member of: • AAMI (Association for the Advancement of Medical Instrumentation) – serves as a voting member of many sterilization standards committees and co-chairs the AAMI ST/WG 5 - Terminology committee • ISO (International Organization for Standardization) – serves as a US expert on the following committees: o ISO/TC 198 WG 5 – Terminology o ISO/TC 198 WG 11 - General criteria for sterilization processes and sterilizing equipment o ISO/TC 198 WG 12 – Information for reprocessing of resterilizable devices o ISO/TC 210 WG 1 – Application of quality systems to medical devices o ISO/TC 210 WG 2 – General aspects stemming from the application of quality principles to medical devices o ISO/TC 210 WG 3 – Symbols and nomenclature for medical devices • RAPS (Regulatory Affairs Professionals Society) – serving as chairperson of the RAPS Twin Cities Chapter and as a member of the RAPS European Council (REC) • Member of ASQ (American Society for Quality).

Rina Nir, CEO, RadBee Ltd

Rina is the CEO of RadBee Ltd, an Atlassian Solution Partner that specialises in helping clients in the life sciences sector with compliance issues related to the implementation of Atlassian tools. She regularly delivers projects within strict validation frameworks, using the Atlassian tools to expedite and optimise the process. Prior to starting RadBee, Rina co-founded a medical devices company and lead its R&D, operations and HR functions. In this role she was involved in the implementation of an ISO 13485 quality system and making submissions to the regulatory authorities in Europe and the United States. This gave her firsthand experience of the challenges of balancing innovation and compliance in life sciences operations and how JIRA can help. She went on to establish RadBee, inspired by her conviction about the key role Atlassian tools can play in modernising R&D and quality processes. Rina regularly writes and presents about issues related to compliance and how JIRA and Confluence can help.