Medical Device Software Tech Note

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Who we are

Specialist Software Development for Life Sciences

Firefinch is a UK-based bespoke software development company delivering custom software solutions for the most complex, regulated environments in life sciences, medtech, and digital health. From software as a medical device (SaMD) to AI-powered research workflows, we partner with innovators who need software that is precise, compliant, and built to perform.

How we can help

Medical device software carries unique demands when developing software: patient safety, regulatory scrutiny, and long approval timelines to name a few. Our team brings hands-on regulatory knowledge and hard-won software engineering experience to help you meet these demands, whatever stage you’re at. 

How we can help:

Our areas of expertise include:

  • Medical device software development — designed and developed in line with IEC 62304, covering the full software lifecycle from risk management to verification and validation
  • Regulatory compliance — software built to comply with 21 CFR Part 11, HL7/FHIR protocols, and delivered under ISO 13485-aligned quality management systems
  • Agile, compliant development — using AAMI TIR45 guidance to bring agile methodologies to regulated environments, enabling rapid prototyping without compromising compliance
  • System interoperability — integrating HL7 and FHIR protocols for secure, seamless data exchange with healthcare systems and electronic health records
  • Algorithms and signal processing — developing robust algorithms and data analysis capabilities that meet the performance demands of diagnostic and treatment devices
  • Machine learning and AI — incorporating AI where it adds clinical or operational value, developed to meet regulatory scrutiny
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