Advena is pleased to welcome Amy Jackson to the team as a Regulatory and Quality Consultant. With nearly ten years’ experience in Quality Assurance and Regulatory Affairs, Amy strengthens our capability to support medical device and in vitro diagnostic manufacturers with robust, practical, and compliant regulatory and quality solutions.
Amy brings extensive experience across the full medical device lifecycle, having previously worked with manufacturers in production all the way to working in consultancy. Amy has experience and an educational background that lends itself to authoring biological safety evaluations including toxicological risk assessments. This breadth of experience enables her to support clients with realistic, risk based guidance that aligns quality systems with regulatory requirements and commercial objectives.
A core focus of Amy’s work is the implementation, remediation, and continuous improvement of Quality Management Systems in line with ISO 13485 requirements. She is an experienced Internal Auditor and has supported organisations as both lead and supporting auditee during external audits conducted by Notified Bodies, ensuring effective preparation, response, and ongoing compliance.
Key Areas of Expertise and Client Support:
- Remediation, implementation, and continuous improvement of ISO 13485 compliant Quality Management Systems
- Internal audits and supplier audits, including preparation for and support during Notified Body audits
- Creation, maintenance, and remediation of Technical Files for medical devices and in vitro diagnostics
- Successful support of compliance to EU MDR 2017/745 and UK MDR 2002
- Writing and review of biocompatibility reports in accordance with ISO 10993
- Clinical Evaluation writing, including legacy devices, with successful review by Notified Bodies
- Post market surveillance activities, including PMS plans, reports, PSURs, PMCF plans, and study plans
- CAPA ownership, non conformity handling, and root cause analysis
- Development and review of SOPs, work instructions, and quality documentation
- Device history documentation and batch release processes
- Support for global regulatory requirements, including FDA compliance and international market access
- Adaptation to client specific standards, including ISO 15189, to meet organisational and market needs
Amy holds a BSc with Upper Second Class Honours in Forensic Science and a Masters by Research in Forensic Science. Her strong scientific background supports a structured, evidence based approach to regulatory and quality challenges.
At Advena, Amy’s quality focused mindset, proactive approach to continuous improvement, and ability to communicate effectively with both clients and Notified Bodies enhance the level of support we provide. Her appointment further strengthens Advena’s commitment to delivering high level regulatory and quality consultancy services to the medical device and in vitro diagnostic sector.
