Medical Devices Compliance & Integration Services

Meta Description:
Kestrel Life Sciences delivers expert medical device compliance and integration services, aligned to ISO 13485, ISO 14971, IEC 62304, MHRA, FDA and EU MDR. Specialists in AVEVA PI, Kepware/OPC and LIMS connectivity.

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medical device compliance UK, ISO 13485 consulting, ISO 14971 risk management, IEC 62304 software validation, MHRA medical devices, EU MDR compliance, FDA SaMD guidance, medical device system integration, AVEVA PI historian, Kepware OPC UA integration, laboratory system connectivity, data integrity medical devices, GAMP 5 validation medical devices

Medical Devices Compliance & Integration

At Kestrel Life Sciences Limited, we help manufacturers, laboratories, and healthcare organisations achieve compliance, connectivity, and confidence in their medical device systems.

Medical devices are governed by rigorous global standards, including:

  • ISO 13485 – Quality Management Systems for Medical Devices
  • ISO 14971 – Application of Risk Management
  • IEC 62304 – Medical Device Software Lifecycle Processes
  • IEC 62366 – Usability Engineering for Medical Devices
  • ISO/IEC 27001 – Information Security for connected devices

We align every project with MHRA expectations, FDA guidance, and EU MDR/IVDR requirements, including AI-enabled Software as a Medical Device (SaMD) and evolving post-market surveillance and cybersecurity frameworks.

Integration with Laboratory & Historian Systems

Compliance is only part of the picture — effective integration unlocks real value. Our engineers specialise in connecting medical devices with wider enterprise and laboratory systems to ensure data integrity, interoperability, and regulatory compliance:

  • AVEVA PI System – advanced historian for real-time operational intelligence
  • Kepware / OPC UA – secure standards-based connectivity across devices, LIMS, and enterprise applications
  • LIMS & Data Platforms – ensuring laboratory data is accurate, traceable, and inspection-ready

This holistic integration ensures a single source of truth across your device ecosystem — critical in demonstrating control to regulators and auditors.

Why Partner with Kestrel Life Sciences?

  • Compliance assured through GAMP 5 (Second Edition) risk-based principles
  • Deep expertise in AI-enabled medical devices and regulatory updates from MHRA, FDA, and EU MDR
  • Proven capability in historian and laboratory integration — ensuring that data is not only compliant, but actionable and trusted
  • Commitment to patient safety, product quality, and data integrity at every stage

Turn Compliance into Confidence

With Kestrel, your medical devices are more than compliant — they are secure, connected, and future-ready.

Kestrel Life Sciences Limited – Experts in Medical Device Compliance, Integration, and Validation.