Service 02
Design & Development
From concept sketches to a verified, manufacturable device — engineered under design controls so the evidence you need for approval is generated as you go.
Capabilities
- Concept and industrial design — rapid concept generation, user-centred design, low-fidelity prototypes.
- Electronics — schematic and PCB design, sensing, power, wireless (BLE), EMC-aware layout.
- Firmware and embedded software — STM32, Nordic and similar platforms, developed to IEC 62304.
- Mechanical — enclosures, mechanisms, fluid paths, DFM for moulding and machining.
- Software and connectivity — companion apps and data pipelines where the device needs them.
- Prototyping and test — functional prototypes, bench testing, pre-compliance to IEC 60601-1.
How we work
Every project runs under a design-control process aligned to ISO 13485: design inputs traced from user needs, risk management to ISO 14971 from the first concept, and verification planned before the first prototype is built. That means no scramble to back-fill documentation when it's time to submit.
What you get
- A working, verified device design and a complete design history file.
- Risk management file, usability engineering file and software documentation.
- A bill of materials and drawings ready for design transfer.