Who We Serve ?

Your Trusted Partner in Compliance, Quality, and technology Innovation for Medical Devices and Software as a Medical Device (SaMD)

Our services are tailored to the unique needs of various clients:

  • Startups developing their first medical devices or SaMD.
  • Established manufacturers expanding into SaMD or connected healthcare devices.
  • Companies integrating AI/ML technologies into medical devices.
  • Consulting firms seeking expert support for medical device and SaMD projects.
  • Manufacturers of traditional medical devices transitioning to compliance with MDR/IVDR.
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Value Streams

We deliver value through flexible engagement models designed to fit your business:

  • Project-based consulting for regulatory and compliance services.
  • Custom product development, testing, and V&V services.
  • Annual retainers for ongoing compliance and quality management support.
  • Licensing and implementation services for SmartEye eQMS solutions via S-Cube.

Different Regulatory Frameworks?

At the heart of our services is Regulatory and Compliance Support,

designed to help organisations navigate the evolving regulatory frameworks across the UK, EU, US, and other key markets. We provide expert guidance on MDR, IVDR, FDA, and ISO 13485 compliance, ensuring that your products meet all necessary standards from initial development through to post-market surveillance. Our regulatory specialists work closely with clients to streamline the certification process, reducing time-to-market while mitigating compliance risks.

Why QMS ?
Would you like additional support or a consultation to explore how we can transform your compliance and quality processes?
Get a Consultation