Services
Every stage, under one quality system
Use us for a single phase or the full journey. Each service runs under our ISO 13485 quality system, so documentation transfers cleanly into your design history file.
01 · Design
Product design & engineering
- Industrial design and human factors
- Mechanical and pneumatic systems
- Electronics and power design
- Embedded firmware to IEC 62304
- Mobile apps and wearable devices
- Test equipment and production fixtures
02 · Regulatory
Regulatory strategy & submissions
- Classification and pathway strategy
- FDA 510(k) preparation
- EU MDR technical documentation
- TGA / ARTG support
- Labeling and IFU development
03 · Testing
Verification & validation
- IEC 60601-1, -1-2, -1-11 test planning
- Test lab coordination and pre-compliance
- Usability engineering to IEC 62366-1
- Biocompatibility to ISO 10993
- Software verification
04 · Manufacturing
Production
- Prototypes and pilot builds
- Design transfer and process validation
- Volume assembly and test
- Device history records per unit
05 · Supply chain
Supply chain, packaging & labeling
- Supplier qualification and audits
- UDI labeling for US and EU
- Packaging design and validation
- Direct shipment to your distributors
06 · Post-market
Sustaining engineering
- Complaint investigation support
- CAPA and design changes
- Component obsolescence management
- Cost-down redesigns
Not sure where to start?
Most clients arrive with either a concept, a prototype, or a cleared design that needs a new manufacturer. We'll recommend the right starting point after one call.