Quality & regulatory
ISO 13485:2016 certified moulding, end to end.
Every process at CPT, silicone moulding, cleanroom manufacture, assembly, packaging and sterilisation, is carried out under our ISO 13485:2016 quality management system, certified by LRQA.
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