Advena is thrilled to welcome Rebecca Roughton, known professionally as Bekkie, to the team as our new Regulatory and Quality Consultant. With extensive expertise in the medical device sector, Bekkie strengthens our ability to support clients with compliance, risk management, and best practice in sterilisation, sterility assurance, and regulatory standards.
Bekkie’s career combines scientific rigour with regulatory expertise. She began as an Embryologist, gaining a strong foundation in biological sciences, and transitioned in 2015 to quality and regulatory roles in the medical device industry. Her experience spans multiple areas critical to manufacturers and innovators:
Key Expertise and Responsibilities:
- Oversight of sterilisation validation for ethylene oxide and gamma-sterilised devices
- Sterility assurance and cleanroom compliance
- Technical file and design history file management for Class I and Class IIa devices
- Risk management planning, analysis, and review
- Post-market surveillance, clinical evaluation, and biological evaluation reporting
- Internal audits, external audits, and liaising with stakeholders, Notified Bodies, and MHRA
- Ensuring compliance with ISO standards, MDR EU 2017/745, UKCA, and FDA regulations
Beyond her professional practice, Bekkie plays an active role in shaping the future of medical device standards. She contributes to several BSI committees and ISO working groups, including:
- CH/198 – Sterilisation and Associated Equipment and Processes
- CH/210 – Quality Management and General Aspects of Medical Devices
- ISO/TC 198/WG1 – Ethylene Oxide Sterilisation
- ISO/TC 210/WG7 – Maintenance Management
- ISO/TC 210/AHG 3 – ISO 13485 Handbook
- ISO/TC 210/AHG 4 – Assessment of ISO 13485
Her participation ensures that Advena remains at the forefront of regulatory developments, enabling us to provide clients with guidance informed by current standards and industry consensus.
Academic and Professional Qualifications:
- Postgraduate Certificate in Clinical Embryology, Association of Clinical Embryologists
- BSc (Hons) in Biological Sciences, Coventry University
Rebecca’s unique combination of scientific background, regulatory expertise, and standards development experience makes her an invaluable addition to the Advena team. She empowers our clients to navigate complex regulatory frameworks, maintain compliance, and achieve operational excellence.
At Advena, we are committed to delivering high-level regulatory and quality support, and Bekkie’s appointment significantly enhances our ability to offer tailored solutions to meet the evolving needs of medical device manufacturers.
