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. ​

Our philosophy is to support your company and help your innovation thrive. We believe in a no-nonsense, simple and pragmatic approach to ensure success. ​

Get in touch to see how we can support you ​