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 where responsibilities included conducting Product Conformity Assessments against the requirements of the European Directive 93/42/EEC. While at BSI, her time was dedicated to products utilizing animal tissues, device-drug combination devices and high-risk wound care products. Following these positions, Jane joined NAMSA in regulatory consulting where she focuses on partnering with manufacturers of high-risk, Class III devices to achieve regulatory approval.

CORE COMPETENCIES

• Development of regulatory and clinical strategies including, regulatory pathways, MDR transition strategies, assistance with Notified Body (NB) selection, attendance of meetings with prospective NBs and managing key meetings with test houses and subcontractors
• Oversight of Gap Analysis of regulatory and clinical strategies, submissions and key documents for MDD to MDR transitions and compliance
• Creation of design dossiers and technical files, including preparation/input into key documents essential requirements, GSPR checklists, risk management documentation and study reports
• Managing programs for medical devices incorporating medicinal substances: provides advice on submission strategies, participates in NB and medicines agency meetings, compiles medicinal substance dossiers (eCTD format) and ASMF, provides guidance on applicants and restricted part content
• Oversight of medical devices programs utilizing animal tissues by providing strategic advice; preparation of submissions in compliance with EN22442 parts 1-3 and Regulation 772/2012; preparation of key documents, including comprehensive documented justification of the use of the animal material
• Serves as an EDQM expert: prepares reports for the TSE monograph and provides assistance with EDQM submissions
• Prepares and reviews Clinical Evaluation Reports (CERs) to MEDDEV 2.7/1 Rev 4 and MDR requirements, as well as MDCG 2020-5 and MDCG 2020-6
• Provides expertise in interpretation and implementation of Medical Device Coordination Group (MDCG) guidance documents
• Oversees regulatory due diligence in relation to mergers, acquisitions and investment projects
• Provides training for CE-marking requirements, including MDR, development of training materials, presentations, seminars and webinars to Client groups

RECENT PROJECTS

• Conducted a Notified Body audit for non-conformance: 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