Certified quality and European regulatory compliance

We work to recognised quality standards and rigorous documentary management that guarantees traceability, safety and conformity in every supply.

Certifications & marks

Quality and conformity frameworks behind every product

CE

CE marking

Products comply with the applicable European Union requirements on safety, health and protection.

ISO 9001

Quality management

Quality management system focused on continuous improvement and customer satisfaction.

ISO 13485

Medical devices

Specific requirements for the quality management system of medical devices.

GDP

Good distribution practice

Distribution compliant with Good Distribution Practices to guarantee product integrity.

Regulatory compliance

Conformity with European regulation across the chain

EU regulation

Compliance with the European regulatory framework applicable to PPE and medical devices.

Full traceability

Record of origin, batch and conditions from receipt to delivery.

Chain of custody

Documented control of approved suppliers and storage conditions.

Declarations of conformity

Technical documentation and declarations available for each reference.

Quality control

A control process at every stage

We apply documentary and physical checks at receipt, storage and dispatch to ensure every shipment meets the agreed specifications.

IMAGE — Quality control / inspection
1

Supplier approval

Selection and audit of manufacturers with valid certifications.

2

Receipt verification

Documentary and physical control of each batch against specification.

3

Controlled storage

Monitored and recorded temperature and humidity conditions.

4

Preparation and dispatch

Check of references, quantities and accompanying documentation.

5

After-sales traceability

Record of delivered batch and management of incidents and claims.

Documentation available

We provide the technical and regulatory documentation you need for your purchasing, audit and validation processes.

CE certificates
Technical data sheets
Safety data sheets
Declarations of conformity
Certificates of analysis
Batch documentation

Need documentation for a reference?

Ask us for certificates, technical data sheets and declarations of conformity for your audit and purchasing processes.

Contact us