Ava is a senior quality and regulatory affairs professional with over 12 years of experience in the IVD and medical device industries. She holds strategic leadership roles overseeing regulatory compliance, quality systems, and product development, with a strong track record of driving innovation while ensuring alignment with international standards and regulations such as ISO 13485 and (EU) 2017/746 IVDR. Ava combines technical depth in immunoassay development with high-level regulatory oversight, making her a key leader in bridging scientific development with robust quality and regulatory governance.
Ava’s experience in the development, evaluation and certification of IVD medical devices, brings a unique dual perspective, enabling her to assess product safety and performance with precision while ensuring alignment with evolving UK and EU regulatory frameworks.

Key Achievements:
William Oak Diagnostics Ltd: As Head of Quality and Regulatory Affairs, Ava leads the design and implementation of the organisation’s quality and regulatory strategies, ensuring full compliance with ISO 13485 and meeting the regulatory requirements for UK, EU and US markets. She serves as the company’s Management Representative, guiding QMS development, overseeing technical documentation and regulatory submissions, and ensuring alignment between innovation, quality, and commercial objectives. Ava is instrumental in establishing a culture of compliance, continuous improvement, and operational excellence across departments.

LNE-GMED UK Ltd: As an IVD Product Reviewer, Ava conducted comprehensive assessments of technical documentation under the IVDD and IVDR for CE and UKCA marking. Her responsibilities included evaluating clinical performance data, coordinating with cross-disciplinary teams, and ensuring technical and regulatory consistency across product reviews. She supported the harmonisation of IVD nomenclature and provided IVDR training and internal knowledge transfer across the organisation. Ava also played an active role in the MHRA’s IDAP initiative, producing regulatory gap analyses for manufacturers.

Mologic Ltd: In her role as Project Manager and Biosafety Practitioner, Ava led major diagnostic development projects from concept to market, overseeing laboratory operations, technical design, and risk mitigation strategies. She managed clinical study planning, quality documentation, and technical compliance with ever-evolving regulatory requirements, while also ensuring biosafety compliance across five laboratories. Her consistent technical success and regulatory alignment contributed to securing multiple contracts and generating over £1 million in revenue.

Omega Diagnostics & Genesis Diagnostics: Ava contributed to the research and validation of immunodiagnostic products, including the challenging development of an HIV point of care test. Her work included assay development, performance evaluations, and technical troubleshooting, with a strong focus on QMS, ISO 13485 compliance, and design control principles.
Comprehensive Industry Expertise: Ava is certified in ISO 13485, ISO 14971, and multiple IVDR modules. She holds advanced training in (EU) 2017/746, IVD clinical performance evaluation, labelling, biosafety, and usability engineering (IEC 62366-1). With an MPhil in Biomedical Sciences and a BSc in Biomedical Science, Ava integrates deep scientific expertise with regulatory acumen, ensuring that diagnostic products are developed to the highest standards of safety, performance, and compliance.