IVD Software & Quality
Fionnuala is an experienced Bioinformatics consultant specialized in the development and delivery of compliant software solutions to support clinical genomic tests.
The key expertise areas of Fionnuala
- The IVD Regulation will require many labs providing companion diagnostic tests to meet the distance sales requirements of the IVDR. This requires labs that are not using CE marked kits to gain compliance for their tests and as a consequence need to blend their existing ISO 15189 or CLIA accredited quality systems with an IVDR/ ISO 13485 system. Fionnuala has experience blending these complex systems for continued compliance to other requirements.
- The IVDR development of software in the IVD space is a specialized area. Many of these products require algorithms and are provided as standalone software, therefore requiring their own approval. Fionnuala's background in human genetics and industry experience is ideal to support these companies.
- For the past 5 years, Fionnuala has supported informatics software projects including planning, structured development and life-cycle management within a regulated framework.
- She provides quality management system advice, implementation, maintenance and accreditation support (e.g. ISO13485, ISO 15189) and regulatory advice for the United States and European markets.
Fionnuala holds a degree in Human Genetics from Trinity College in Dublin, and has worked for personalized medicine companies for over 11 years holding senior positions covering bioinformatics, IT infrastructure, quality and regulatory affairs. She also earned an MSc in Bioinformatics from Dublin City University.
Her background includes experience in the creation of quality management systems for
compliance to both ISO 13485 and ISO 15189, as well as other lab accreditations, including the IVD Directive and Regulations. This is an essential skill in the growing field of companion diagnostics
Learn more about our services within EU-IVDR