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Jane Arnold-Round, MSc

Senior Principal Consultant, Regulatory

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Jane Arnold-Round has 30 years of experience in the medical device industry working with a broad range of medical device technologies and organizations from start-ups to multinationals.

Jane began her career with Medtronic and then Sulzer Vascutek before joining BSI in 2000. In this role, she was involved with a broad range of devices with particular responsibility for the wound care sector, device-drug combinations and medical devices utilizing non-human tissues. She was a Notified Body reviewer for over 15 years, working as an external expert with several Notified Bodies. A regulatory consultant for 20 years, she joined the medical device regulatory consulting team at NAMSA in 2018, where she focuses on complex regulatory submissions and partnering with manufacturers to help them successfully transition their devices to the MDR.

Jane holds a Bachelor’s Degree in Engineering from Leeds University (United Kingdom) and a Master’s Degree in Bioengineering from Strathclyde University (United Kingdom). In addition, she is the convenor of ISO/TC194/WG19 committee on Tissue Product Safety and an active Member of the ISO/TC194 committee on Biological Evaluation of Medical Devices.


  • Development of regulatory, clinical and classification strategies including, regulatory pathways, MDR transition strategies and PMCF strategies
  • Gap Analysis of technical documentation, regulatory submissions, and key documents for compliance including MDD to MDR transitions
  • Assistance with Notified Body (NB) selection, attendance of meetings with prospective NBs and managing key meetings with test houses and subcontractors
  • Management of submission preparation: coordination of projects involving multiple writers to achieve submission timelines
  • Creation of technical documentation, including preparation/input into key documents GSPR checklists, risk management documentation and study reports
  • Borderline product determinations including systematic reviews of scientific literature to support modes of action in line with MDCG 2022-5
    • Development of supporting technical documentation for regulatory submissions
  • Medical devices incorporating medicinal substances: advice on submission strategies, participation in NB and medicines agency meetings, compilation of medicinal substance dossiers (eCTD format) and Active substance master files (ASMF)
  • Medical devices utilizing non-human tissues: strategic advice, liaison with suppliers, participation in NB audits, preparation of submissions in compliance with EN ISO 22442 parts 1-3 and Regulation 772/2012
    • Preparation of key documents, including comprehensive zoonotic risk literature reviews risk-benefit analysis for the animal material, preparation of expert reports for the EDQM TSE monograph
  • Oversight, review and preparation of Clinical Evaluation Reports (CERs) to MEDDEV 2.7/1 Rev 4 and MDR requirements and relevant guidance such as MDCG 2020-5 and MDCG 2020-6
  • Regulatory due diligence concerning mergers, acquisitions and investment projects
  • Bespoke training for CE-marking requirements including MDR, development of training materials, presentations, seminars and webinars for Client groups


  • Emergency client support to address intractable Notified Body non-conformities, including detailed written responses, review and input of documents, liaison with key supplier and attendance of Notified Body audit successful outcome with Client product achieving CE-mark certification
  • Oversight of MDR transition project rectifying weaknesses in a Sponsor’s technical documentation and developed an efficacious MDR clinical strategy
  • Developed a regulatory and clinical strategy for an early-stage device business; project included NB selection, meetings with Competent Authorities and development of clinical study design
  • Strategic support for borderline devices, including classification strategy


  • RAPS 2021 US Convergence: Alternative Clinical Evaluation Strategies
  • RAPS 2020 EURO Convergence: MDR Technical Documentation for Legacy Products: Practical Tips and Tricks, PMS, PMCF and Clinical Data
  • RAPS 2020 US Convergence: Preparing a Technical File for the MDR: New and Nuanced Requirements
  • TOPRA Essentials of European Medical Device Regulatory Affairs Course. Speaker (2019)
  • How to Ensure Your Clinical Evaluation Reports (CER) Comply with EU MEDDEV 2.7/1 rev 4 Emergo Webinars (2017 & 2018)
  • Emergo Japan Seminar (Tokyo and Osaka) September 2018. Sole presenter:
    • MDR and IVDR New Medical Device Regulations in Europe
    • EU clinical data requirements for medical devices MEDDEV 2.7/1 Rev 4 and the MDR
  • NAMSA: UK Extends Transition Period For Medical Device And IVD Products In New Legislation
  • NAMSA: EU commission publishes MDR implementing regulation for devices without medical purpose (Annex XVI)
  • NAMSA: New MDCG 2022-5 Guidance On Borderline Between Devices And Drugs Under MDR