Industry

Medical Devices & Healthcare Technology

Design, validate and manufacture devices that regulators trust and clinicians rely on.

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Overview Challenges What we deliver Capabilities Standards Case studies

Overview

How we work in medical devices

We support medical device companies from Class I consumables to Class III implantables and active devices. Our engineers work under ISO 13485 design controls, deliver verification and validation evidence, build the manufacturing and test equipment, and prepare the technical documentation for CE, FDA and CDSCO approval.

Challenges we solve most often

  • Meeting ISO 13485, EU MDR and FDA design-control expectations without slowing development
  • Proving biocompatibility, usability and electrical safety through structured V&V
  • Scaling from prototype to GMP production with validated equipment and processes
  • Introducing AI and software into devices under IEC 62304 and ISO 14971

What we deliver

Engineering, validation and digital solutions for medical devices

  • Design and development under design controls with complete design history files
  • Mechanical, thermal, fluid and electromagnetic simulation for device performance and safety
  • IEC 60601 pre-compliance planning and test support
  • Cleanroom, assembly and automated test equipment with IQ/OQ/PQ
  • Software and AI development to IEC 62304 with cybersecurity and risk management
  • Regulatory technical documentation for CE marking, 510(k) and CDSCO

Capabilities applied

Disciplines we bring to medical devices programmes

Design & Development

From a blank sheet to production-ready drawings, with manufacturability built in.

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Validation & Qualification

Commissioning, qualification and validation that regulators accept the first time.

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Regulatory & Compliance

Engineering that clears CE, FDA, PED, ASME and national approvals without rework.

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Special Purpose Machines

Machines engineered around your part, your process and your throughput target.

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AI & Machine Learning

Applied AI built by engineers who understand the machines the data comes from.

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Additive Manufacturing

Prototypes in days, qualified printed parts in production.

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Simulation & Analysis

Virtual testing that removes physical iterations and de-risks design decisions.

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Software Engineering

Industrial-grade software that connects the shop floor to the boardroom.

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Codes, standards and regulations

Frameworks we engineer and document to in this sector

Compliance is designed in from the first specification, not audited in at the end.

  • ISO 13485
  • ISO 14971
  • IEC 60601
  • IEC 62304
  • ISO 10993
  • EU MDR 2017/745
  • 21 CFR 820
  • ISO 14644

Representative engagements

Medical Devices case studies

Medical Devices

Automated verification system for a Class II infusion pump line

Designed, built and qualified an end-of-line flow-accuracy and occlusion test system with 21 CFR Part 11 compliant data capture.

80%Reduction in test cycle time
ZeroInspection observations

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Planning a medical devices project?

Our sector engineers will review your scope and come back with options, risks and a realistic plan, at no cost for the first conversation.

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