3 | Process Development

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.