Manufacturer assessment
Evaluation of manufacturing capabilities and suitability for the product.
Quality & compliance
Confidence built into
every stage.
Quality and regulatory requirements are managed throughout the sourcing and manufacturing process, from manufacturer assessment to final documentation.
Quality on the ground
Direct oversight where
production happens.
Our dedicated quality team in China works directly with manufacturing partners, providing local oversight of production and allowing issues to be addressed at source.
Requirements are established for each product according to its classification, intended use and destination market.
Specification
Confirmation of materials, construction, dimensions, performance and packaging.
Production control
Monitoring against the agreed product specification and quality requirements.
Testing
Coordination and review of relevant product testing and supporting reports.
Inspection
Product and packaging inspections as appropriate before shipment.
Documentation
Review of certificates, declarations, test reports and regulatory documentation.
Market-specific compliance
One product.
The right regulatory route.
Products are assessed separately for their intended use, classification and destination market.
EU
European market
European compliance
Products supplied to the European market are assessed against applicable EU regulatory requirements.
- Regulation (EU) 2016/425Personal Protective Equipment
- Regulation (EU) 2017/745Medical Device Regulation (MDR)
- CE markingConformity assessment and documentation
- Technical documentationTesting, declarations and Notified Body review where required
US
United States market
US compliance
Products intended for the US market follow a separate assessment against applicable US requirements.
- FDA requirementsApplicable requirements for the individual product
- Product classificationClassification according to intended use
- Registration & listingRelevant establishment and product requirements
- Pre-market requirementsRecognised performance standards and required routes
Important: The regulatory route is determined by the individual product, its classification and intended use. Requirements are reviewed on a product-by-product basis.
Document control
The paperwork matters
as much as the product.
Supporting documentation is reviewed as part of the quality process to help ensure the required evidence is in place before supply.
✓ Certificates
✓ Declarations of conformity
✓ Test reports
✓ Technical documentation
✓ Packaging requirements
✓ Labelling requirements
Product requirements