Heather Carre-Skinner

Medical Device Regulations, Heather Carre-Skinner, PhD

Heather Carre-Skinner

Software As A Medical Device, Digital Health Medical Devices, and In-vitro Diagnostic Devices, Cybersecurity, Wellness Devices

Heather Carre-Skinner, PhD Biography

As the Director and Principal Consultant at Fieldfare Consulting, I bring over 15 years of expertise in Quality Assurance and Regulatory Affairs within the medical devices and diagnostics realm. I started off my career in science and my academic background includes a PhD in Molecular Microbiology from the University of London. Prior to my current role, I served as a senior scientist within both the NHS and private biotech sectors, before I transitioned into the domain of Quality and Regulatory.

Throughout my career, I’ve navigated diverse sectors such as in-vitro diagnostics, medical devices, software as a medical device, and data security and privacy. My proficiency extends to implementing quality and business management systems (ISO 13485, ISO 9001, and ISO 27001) across companies of varying scales, coupled with staff training initiatives.

I possess a track record of successfully obtaining CE marks for medical devices and in-vitro diagnostics, in addition to compiling technical files for various regulatory territories. Leveraging my distinctive professional journey, I merge business acumen with scientific insight to deliver unparalleled consulting services. The motto at Fieldfare Consulting is “Helping Innovation Thrive” and I have positioned my company as friendly, honest and committed to help you on your company journey.

Heather Carre-Skinner, PhD Services

  • Strategic Planning for your product or service: including regulatory requirements, costs and timelines.
  • Setting up quality and business management systems (ISO 9001, 27001, 13485) to drive excellence in your company.
  • Technical file writing, assembly and remediation for your product, ready for regulatory submission.
  • Training for small and large stakeholder groups to understand and master requirements for getting their product or service to market.
  • Monthly retainer for ad-hoc support and advice to facilitate your companies success.

Locations of Work

UK, EU and US

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Podcast Episodes

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