Quality & regulatory
Every process, under one accredited quality system.
All operations at CPT are carried out under our ISO 13485:2016 quality management system — from moulding and cleanroom manufacture through to assembly, packaging and sterilisation.
ISO 13485:2016
All operations carried out under a quality management system accredited to ISO 13485:2016.
Cleanroom governance
ISO 8 Class K (100,000) cleanroom procedures governing moulding, assembly, inspection and packaging.
Traceability
Batch traceability from incoming material through to final packaged product.
Non-contact dimensional inspection
High-resolution optical measurement of complex geometries without physical contact — ideal for soft, flexible or delicate elastomeric parts. We can quickly verify critical dimensions, wall thickness, form and surface profile across low-volume trials and high-volume production.
Design & material control
Structured input at project inception, including design and material selection support.
Sub-contract sterilisation
Final sub-contract sterilisation available to deliver ready-to-use packaged product.
Current certification
ISO 13485:2016 — LRQA
The manufacture of elastomeric components and assemblies for medical applications.
- Approval number
- 00008993
- Certificate no.
- 10749203
- Original approval
- 30 March 2017
- Current issue
- 30 March 2026
- Expiry
- 29 March 2029
- Issued by
- LRQA Limited