HealthTech & Medical
Device Engineering
Building Compliant
Medical Devices
MedTech teams often struggle with:
- Navigating FDA 510(k) and EU MDR regulatory pathways
- Maintaining a complete and structured Design History File
- Meeting IEC 60601 electrical safety requirements
- Addressing cybersecurity requirements for connected devices
Without embedded regulatory expertise, medical device programmes face submission rejection, costly rework, and delayed market entry.
End to End Services
A fully documented, regulatory-aligned engineering process from design input to technical file
We capture clinical intended use, user needs, and design inputs to form the foundation of your Design History File.
What We Deliver
- IEC 60601 Compliant Hardware
- ISO 14971 Risk Management
- Design History File Support
- FDA & CE MDR Submissions
Engineered for Patient Safety
We embed regulatory thinking into every design decision, ensuring your device is safe, compliant, and ready for clinical use.
Risk Management by Design
ISO 14971 risk management is integrated throughout development, not bolted on at the end. We systematically:
- Identify hazards during architecture definition
- Implement hardware and software risk controls
- Maintain a complete risk management file
- Verify residual risk acceptability before V&V
Technologies & Tools
From early feasibility to production-ready design, we ensure every concept is technically validated and manufacturing-aligned.
Yes. We maintain structured engineering documentation throughout development aligned to 21 CFR Part 820 and ISO 13485 quality management requirements. Our deliverables are designed to slot directly into your DHF.