Raw material verification
Incoming latex, non-woven, film, resin and packaging materials are checked against agreed specifications before entering production.
Quality & Certificates
Documented quality management from raw material to shipment
Quality management system
Our manufacturing partners operate quality management systems certified to ISO 13485, with products CE marked where the European Medical Device Directive and Regulation apply. Every batch is produced against a written specification, inspected before release and recorded so that it can be traced after delivery.
Control at every stage
In-process control
Dimensional checks, weight and function tests are performed during production, not only at final inspection.
Sterilisation and validation
EO and radiation sterilisation cycles are validated, monitored and documented for every batch.
Final inspection and release
Sampling plans, packaging integrity and labelling are verified before goods are released for shipment.
Certifications
The following documentation is available for qualified buyers.
- ISO 13485 — Quality management system for medical devices
- CE — European conformity marking for applicable product families
- FDA — Establishment registration and product listings where applicable
- Free sale certificate — issued for registration in your market
- Test reports — ASTM, EN and ISO test results for the relevant standards
- Material safety data sheets — for chemical and disinfection products
OEM and private label
We produce under your brand with your artwork, packaging, language and regulatory labelling. Our team can prepare dielines, review artwork for compliance with labelling rules and supply pre-production samples before the full run.
Need a specific certificate or test report?
Tell us the product and the destination market and we will send the documents you need.