Our Process
Product Lifecycle
We offer complete end-to-end services to take your product innovation through its development stages, from early feasibility to manufacturing. Our tried and tested processes allow swift progression from a development stage to a fully validated production process and manufacturing. Operating under ISO 13485 guidelines since 2015, we can provide the full suite of documentation for regulatory submissions worldwide. We will be your partners with a focus on downstream cost-of-goods, right from the beginning.
1 | Feasability
2 | Product Development
3 | Process Development
4 | Process Validation
5 | Manufacturing
2 | Product Development
4 | Process Validation
1 | Feasibility
- Rapid proof-of-concept electrospinning studies.
- Design for manufacturability and cost from day one.
- Early screening of polymers and processes.
- Risk identification leveraging 100+ projects of experience.
2 | Product Development
- Iterative prototyping to optimise fibre and scaffold properties.
- Test method development and validation for CTQ requirements.
- Production of clinical-grade material in ISO Class VII cleanrooms.
- Full design control documentation under ISO 13485
3 | Process Development
- Scale-up from lab to pilot to production scale.
- Statistical process control to ensure consistency.
- Process optimisation via design of experiment.
- Modular production and ISO-certified supply chain for flexibility.
4 | Process Validation
- Equipment and process validation (IQ, OQ, PQ).
- ISO 13485 documentation ready for audits and submissions.
- ISO 13485 documentation ready for audits and submissions.
- Comprehensive mechanical, chemical, and sterility QC testing.
5 | Manufacturing
- Clinical-grade manufacturing in ISO Class VII cleanrooms.
- High-throughput production with multi-nozzle electrospinning.
- Supply of electrospun parts for FDA-approved and CE-marked implants.
- Global delivery with ISO-compliant quality assurance.
Our Technology Platforms
Biosynthetic materials combining natural compounds with synthetic fibres for enhanced biocompatibility
