Heather is director and principal consultant at Fieldfare Consulting, and has over 15 years’ experience within Quality Assurance and Regulatory Affairs of medical devices and diagnostics.
Heather has a PhD in Molecular Microbiology and has worked as a senior scientist within the NHS and private biotech, before moving into the world of Quality and Regulatory. Heather combines business acumen and scientific understanding to offer a unique perspective to consulting services.
Heather has worked within different regulatory areas; in-vitro diagnostics, medical devices including software as a medical device.
Heather has extensive experience in successfully implementing quality management systems (ISO 13485 and ISO 27001) in companies of different sizes as well training of staff.
Heather has also successfully CE marked medical devices and in-vitro diagnostics, as well as compiled technical files for different regulatory territories.
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