Advena is delighted to welcome Laura Taylor to the team as a Regulatory and Quality Consultant. With over ten years’ experience in regulatory affairs and quality management, Laura brings extensive expertise across the medical device lifecycle, supporting manufacturers of Class I, IIa, and IIb devices, including implantable and combination.
Laura has a strong track record in delivering regulatory and quality solutions from product development to post market compliance. Her experience spans CE marking, Quality Management Systems, clinical evaluation, and regulatory submissions under MDR, UK MDR, and international frameworks. By combining strategic insight with hands-on delivery, she helps clients achieve compliance efficiently while maintaining operational momentum.
A core strength of Laura’s work lies in technical documentation and regulatory strategy. She has authored and remediated technical files, Clinical Evaluation Reports, and post market documentation, and has successfully supported regulatory submissions and Notified Body interactions. Her experience includes rebuilding technical documentation to reinstate CE marking for a Class IIb implantable device and delivering MDR transition strategies for multiple legacy products.
Key Areas of Expertise and Client Support:
- Regulatory strategy and lifecycle management for Class I, IIa, and IIb medical devices
- CE marking, MDR and UK MDR compliance, and regulatory submissions
- Technical file authorship and remediation, including implantable devices
- Clinical Evaluation Reports, post market surveillance, and PMCF activities
- Quality Management System implementation, integration, and improvement
- ISO 13485 compliance, audit readiness, and certification maintenance
- Internal, supplier, and external audit support, including Notified Body engagement
- Risk management, vigilance, and regulatory oversight of product claims
Laura is a Certified ISO 13485 Lead Auditor and has led and supported audits across multiple regulatory frameworks, including MDSAP. She has experience working directly with regulators and Notified Bodies, providing clients with confident, informed representation throughout audits and regulatory reviews.
Academically, Laura holds an MSc in Strategic Quality Management and a BSc with Honours in Marine Biology. She is a registered member of TOPRA and contributes to industry knowledge through published work focused on regulatory transition and Quality Management Systems.
Laura also has a position on the editorial board for the TOPRA journal, Regulatory Rapporteur, where she contributes to the development and review of articles relevant to medical devices as well as helping to shape the journal’s focus. This work allows her to keep closely engaged with current regulatory thinking and emerging topics.
At Advena, Laura’s combination of regulatory leadership, technical expertise, and practical delivery strengthens our ability to support clients navigating complex regulatory environments. Her appointment further enhances Advena’s commitment to providing high-quality regulatory and compliance consultancy for the medical device sector.
